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									R e g i s t e r b y M a y 2 1 , 2 0 1 0 a n d R e c e i v e $ 2 0 0 O f f o f Yo u r R e g i s t r a t i o n F e e !

                                                          IVT’s 7th ANNUAL



     METHOD
       VALIDATION
      Designing Quality in Methods that Survive the Lifecycle
    BEST-IN-CLASS!                                    July 28-30, 2010 • Sir Francis Drake Hotel • San Francisco, CA
           Anne-Marie Alderson, MBA,
          Quality Engineering Manager,
                Cook MyoSite Inc.                     Customize Your Conference by Choosing
               Claire E. Brook, Ph.D.,                Specific Method Validation Topics Including:
      Senior Research Chemist, Covidien
           Shreekant Karmarker, Ph.D.,                •     Method Development of a Chemical Assay
     Senior Research Scientist, Global R&D,
                Baxter Healthcare                     •     Handling Deviations and Unexpected Results during Method Validation
     Alice Krumenaker, ASQ CQPA CMQ/OE                •     Stability Indicating Method Validation
       ASQ Certified Six Sigma Green Belt,
        Process Manager, Quality System,              •     Validation of Analytical Test Methods for Cleaning Samples
                    Merial Ltd.                       •     Producing Useful Method Validation Protocols and Reports
    David LeBlond, Ph.D.,Principal Research
                Statistician, Abbott                  •     Development and Validation of Peptide Methods
          Ernest Lee, Master of Science,              •     Six Sigma Applications in Method Validation
   Senior Manager, Facilities and Engineering,
                  Medarex BMS                         •     Fast HPLC Method Development and Validation
                Sue Mecham, Ph.D.,                    •     Change Control during Method Development
        Director of Laboratory Operations,
       Polymer Solutions Incorporated
                                                      Plus! Choose between Three Cutting-Edge,
            Cynthia Rancourt, B.ScN.,                 Interactive Workshops on:
         Director of Business Operations,
       Polymer Solutions Incorporated
              Upen Shah, B.S., MBA,
                                                      •     Method Transfer — Crossing Multiple Borders
      Senior Director, Quality Management,            •     Applying Quality-by-Design (QbD) Based on Risk Assessment to Achieve a
           Amneal Pharmaceuticals
                                                            Fundamental and Practical Understanding of Method Validation
              Rafail Usatinsky, Ph.D.,
          Analytical Research Manager,                •     Analytical Instrument Qualification (AIQ)
  Cedarburg Hauser Pharmaceuticals, Inc.
            Xiande (Andy) Wang, Ph.D.,                And! Don’t Miss the FDA Keynote Address:
    Principal Scientist, Cordis Corporation
              Weifeng “Frank” Zhang,                  Alfred V. Del Grosso, Ph.D., Team Leader — Analytical Chemistry,
   Master of Engineering, Validation Manager,
                                                      FDA — Center for Biologics Evaluation and Research, Office of Vaccines
                  Medarex BMS
                                                      Research and Review, Division of Product Quality (via teleconference)
             And many more!
                                                      Supporting                                     Lead Media Partner:     Outstanding
                   Organized By:                      Sponsor:                                                               Support
                                   Subsidiaries of:                                                                          Provided by:




                                                      TO REGISTER CALL TOLL FREE 800-817-8601 OR REGISTER ON OUR WEBSITE AT WWW.IVTEVENTS.COM/METHODVAL
 DAY ONE • WEDNESDAY, JULY 28, 2010 • 8:30a.m. – 12:15p.m. • General Sessions


7:30    Conference Registration                                                           • A review of cGMP requirements with respect to analytical procedures
                                                                                          • Expectations regarding the adoption of compendial
8:30    Chairman’s Opening Remarks                                                            procedures and the transfer of methods from R&D or other
        Jerry Lanese, Ph.D., President, The Lanese Group LLC                                  sources to manufacturing
                                                                                          • Reporting requirements for changes to approved procedures
8:45    How Can a New Process Validation Guidance Impact                                  • Examples of deficiencies that have delayed the approval of
        Test Method Validation?                                                               analytical procedures
        In 2008, the FDA issued a new guidance for process validation.                    Alfred V. Del Grosso, Ph.D., Team Leader — Analytical Chemistry,
                                                                                          FDA — Center for Biologics Evaluation and Research,
        Although the practice of method validation was conceived long
                                                                                          Office of Vaccines Research and Review, Division of Product Quality
        before the FDA started to advocate process validation, the original,              (via teleconference)
        1987, FDA guidance on process validation had an impact on
        test method validation. That impact continues as the industry             10:15   Networking and Refreshment Break
        interprets and implements the new process validation guidance.
        This session discusses what is new in the process validation              10:45   Ensure Method Validation Compliance
        guidance, how that changes the practices in process validation and                through a Review of FDA Warning Letters
        the impact on test method validation. Key points include:                         This session trends method validation observations as seen in
        • Why there is a need for a new process validation guidance
                                                                                          FDA Warning Letters. Organizational controls are discussed
                                                                                          from a quality assurance perspective. This session evaluates
        • What is new in process development and process validation                       and categorizes the observations, which allows for use as tools
          that will impact test methods and their validation                              for compliance.
        • Additional new guidance that will impact test methods and                       • Trends in method validation observations
          their validation                                                                • Roles and responsibilities of quality control
        • The test method validation timeline                                             • Conduct an appropriate assessment of personnel, system
                                                                                            and process controls
        • New process validation guidance and method validation characteristics
                                                                                          • Develop documentation that maintains compliance
        Jerry Lanese, Ph.D., President, The Lanese Group LLC                              David T. Lin, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.

9:30    A CBER Regulatory Perspective on Analytical
        Procedures — Key Parameters that Require Validation                       11:30   Enhancing Analytical Quality Through the Use Of UPLC —
        Procedures to support the identity, strength, quality, purity and                 One Method in Place of Two
                                                                                          A UPLC method was developed and validated for simultaneous
        potency of drug products and drug substances are an important
                                                                                          quantitation of related substances in a combination drug product
        component of new product applications reviewed by the FDA.                        containing two active pharmaceutical ingredients (APIs). The
        Analytical procedures used for product characterization and control               method was shown to separate the four known degradation
        must be validated; validation studies must be documented and                      products as well as API-related impurities and unknown related
        submitted as part of the application. Procedures used in both                     substances. The enhanced UPLC method allows for more reliable
        pre-approval studies in support of product applications and post-                 and efficient testing of the product relative to the current state in
                                                                                          which testing was conducted via two separate HPLC methods. Key
        approval manufacturing must be implemented in accordance with                     points include:
        current good manufacturing practices (cGMPs). In this presentation,               • Development of a single UPLC method to replace two separate
        the statutory basis for FDA regulation of analytical procedures                      existing HPLC methods
        and laboratory practices is reviewed along with current policies                  • Validation of the UPLC method
        and practices as to how reviews are performed by FDA’s Center for                 • Comparison of UPLC approaches versus HPLC
        Biologics Evaluation and Research (CBER). Guidance documents                      Corinne Mounier-Lee, Ph.D., Principal Scientist, Catalent Pharma Solutions
        relevant to analytical procedures are reviewed. Some specific topics
        to be discussed include:                                                  12:15   Networking Luncheon

                     W E L C O M E                             I N T E R E S T E D                      S P O N S O R S :
  IVT’s corporate sponsors represent select companies that share a common mission: business advancement through thought leadership,
     strategic interaction and innovation. The companies represented below are proud contributors on this program and have carefully
 selected messaging, branding or positioning statements to encourage the evaluation and investigation of quality products and/or services
 available. We applaud these companies, as well as others that wish to join the conference as important members of this event’s delegation.




       For additional information on sponsorship or exhibit opportunities, please contact Eileen Katis at 339.298.2152 or at eileen.katis@cbinet.com.
                         DAY ONE (CONT) • 1:30-5:00p.m. • Choose Between Three Interactive Workshops
           1 : 3 0                 W o r k s h o p                 L e a d e r s ’            W e l c o m e                a n d       O p e n i n g                   R e m a r k s

                         Workshop A                 •      Applying Quality by Design (QbD) Based on Risk Assessment to
                              Achieve a Fundamental and Practical Understanding of Method Validation
      The objective of this workshop is to develop an                          II. Designing a Practical Method Validation                  process validations are explored with respect
      understanding of the benefits of Quality-by-Design                           by Understanding Process Variation                       to the risk assessment determination of critical
      (QbD) and how to best utilize these concepts to design                                                                                parameters. Participants also discuss real world
                                                                                   •   Product and process knowledge                        challenges and FDA warning letters related to
      and perform method validation that is effective and                          •   Effective brainstorming                              method validation issues and how to avoid them.
      practical. Taking a step back and understanding where                        •   How to develop and use Fishbone diagrams
      method validation fits into the QbD process is critical to                   •   How to develop and use FMEA and DOE
      using it effectively as a tool to improve your products,
                                                                                                                                            Bonus Material
                                                                               III. Determining the Requirements for                        • A method validation procedure
      processes and business.
                                                                                                                                            • Templates for method validation protocols
                                                                                    Various Types of Method Validation                        and reports
      I.                  What is the Purpose and Evolution                         Protocols and Reports                                   • Links to available resources for tools and
                          of QbD?                                                  • Developing and writing concise method                    relevant documents
                          • The role of risk assessment, method                      validation protocols                                   • An example FDA warning letter with plans
                            development and validation                             • A template for method validations                        for avoiding them
                          • Relevant ISO/ICH standards and                         • Who approves the method validation?
                            how they address QbD                                     How and based on what?                                 Sue Mecham, Ph.D., Director of Laboratory Operations,
                                                                                   • When does a method have to be re-validated?            Polymer Solutions Incorporated
                          • Differences in the quality systems of the                                                                       Cynthia Rancourt, B.ScN., Director of Business Operations,
                            device and pharmaceutical industries               IV. Interactive Exercise                                     Polymer Solutions Incorporated
                          • The relevance of an automobile industry                Participants review examples of protocol
                            developed quality tool — Six Sigma                     development for various types of method and         5:00 Close of Workshop A


                              Workshop B                 •      Method Transfer — Crossing Multiple Borders
           I.             How to Simplify a Method by Combining                III. How to Transfer a Method Cross Functions           V.   Interactive Exercise
                          Multiple Methods into One                                • Planning a method transfer                             Using the case studies included in the above
                          • How to develop stability indicating composite          • Risk assessment in method transfer                     sections, attendees are divided into three groups
                            assay method                                                                                                    to represent different functions (R&D, QA, QC) in a
                                                                                   • Handling unexpected events during
                          • What is important in developing content                                                                         typical pharmaceutical/medical device company
                                                                                     method transfer
                            uniformity method?                                                                                              and challenge the method transfer process for
                          • Secondary identification method                        • Documentation and report writing for                   further improvement.
                                                                                     method transfer
                          • Advantages of combining three methods into one
                                                                                                                                            Xiande (Andy) Wang, Ph.D., Principal Scientist,
           II. How to Transfer a HPLC Method into UPLC                         IV. Strategy of Method Transfer                              Cordis Corporation,
                          • What are the critical parameters in transferring       • Defining the goals of end method                       A Johnson & Johnson Company
                            HPLC method into UPLC?                                 • Building platforms for dynamic involvement of
                          • Validation of two methods in parallel                    multiple players                                  5:00 Close of Workshop B
                          • Direct comparison of HPLC method vs. UPLC              • Transferring the knowledge, not just the method


                         Workshop C               •      Analytical Instrument Qualification (AIQ)
           I.             Regulatory Expectations for AIQ                          • Installation Qualification (IQ)                        • Improve efficiency of the process
                          •   Define the key terms                                 • Operational Qualification (OQ)                         • Know what advanced technology is available
                          •   Understand the regulations                           • Performance Qualification (PQ)                         • Fit for intended use
                          •   Review FDA Warning Letters                           • Software validation strategies
                          •   Why qualification before method validation                                                               V.   Interactive Exercise
                              is important                                         • Implement change control procedures                    Attendees break into small groups to discuss
                                                                                   • Understand documentation requirements                  their real world challenges and benchmark
           II. USP <1058> — Analytical Instrument                                    for AIQ                                                against their peers to find solutions.
               Qualification Guidance                                              • Know instrument categories
                          • A review of Guidance USP <1058>                                                                                 Paul St. Jean, Senior Product Marketing Manager,
                                                                                   • Define roles and responsibilities
                          • History and terms                                                                                               Waters Corporation
                          • Strategies to ensure data quality                  IV. Analytical Instrument Qualification —               5:00 Close of Workshop C
           III. Developing a Roadmap for the AIQ Process                           Case Study Application
                          • Design Qualification (DQ)                              • Determine what is important to test

                                    There will be a 30-minute networking and refreshment break at 3:00p.m.
Photo by: Getty Images




                                         5:00-6:00           Networking, Wine & Cheese Reception
                                                                   Join friends and colleagues in a relaxed setting.
     Day TWO — Main COnferenCe                                                                                          ThursDay, July 29, 2010

                7:45     •    Continental Breakfast hosted by:


                        8 : 4 5        C h o o s e          B e t w e e n             T h r e e         9 0 - m i n u t e            S e s s i o n s              ( 1 - 3 )

     session 1 •              Method Development of a Chemical Assay — Specificity, Accuracy, Precision
I.    Method Development of a Chemical Assay                 III. Measuring the Precision of an Assay                   V.     Interactive Exercise
      •	 Literature	reviews	that	set	the	basis                     •	 Thinking	about	what	elements	of	precision		              Participants	conduct	an	interactive	discussion		
      •	 What	you	need	to	learn                                       are	critical                                             on	the	development	of	a	new	analytical		
      •	 What	is	the	purpose	of	the	assay	and	how	                                                                             procedure	during	the	early	stage	of	product	
                                                                   •	 Why	precision	is	critical	to	accuracy
         does	this	define	the	specificity?                                                                                     development.		Each	group	plans	the	development	
      •	 Consideration	for	choosing	the	type	of	assay              •	 Defining	repeatability,	intermediate	precision	          of	the	procedure.
                                                                      and	reproducibility
II. How to Work with Specificity                                                                                               Bonus Material
      •	 Process	information	that	is	needed                  IV.    How to Define Accuracy                                     •	 A	copy	of	the	most	recent	guidance	document	
      •	 Stability	information	that	must	be	understood
                                                                   •	 The	need	for	reference	standards                            on	analytical	method	validations	
      •	 Understanding	the	chemistry	of	the		
         analytical	procedure                                      •	 Use	of	theoretical	standards                             Steven S. Kuwahara, Ph.D., Principal Consultant,
      •	 Combining	elements	to	define	specificity                  •	 Defining	the	accuracy	of	a	test                          GXP BioTechnology LLC

     session 2 •               Stability Indicating Method Validation — Is it Unique?
I.    Stability Testing as It Relates to                     II. Material Degradation                                   IV. Challenges Associated with the
      Product Lifecycle                                            •	   Conditions                                          Stability Indicating Study
      •	   Drug	substance	and	drug	product                         •	   What	is	enough?                                        •	   What	are	the	current	challenges?
      •	   When	do	we	perform	stability	testing?                   •	   Interactive	discussion	of	current	practice             •	   Identification
      •	   Validation	of	the	stability-indicating	method           •	   Suggested	degradation	schemes                          •	   Reference	materials
      •	   Documentation	and	current	practice                                                                                  •	   Mass	balance	and	other	challenges
                                                             III. Interactive Exercise
                                                                   The	participants	are	asked	to	propose	an	                   Jerry Lanese, Ph.D., President,
                                                                   experimental	scheme	for	demonstrating		                     The Lanese Group LLC
                                                                   that	the	test	method	for	a	model	product	is	
                                                                   stability	indicating.

     session 3 •               Handling Deviations and Unexpected Results During Method Validation
I.    Elements of Method Validation                                •	 Reporting	findings	and	observations                      •	 Avoiding	common	pitfalls
      Documents and Deviations                                     •	 Documenting	OOS	and	protocol	exceptions
      •	   Regulatory	expectations		                               •	 Preparing	for,	and	documenting,		                 IV. Interactive Exercise
      •	   Guidance	documents	of	regulatory	agencies                  change	control	                                          Using	examples	from	past	FDA	inspections,	
      •	   Protocol	and	report	evaluations                                                                                     attendees	identify	and	analyze	for	handling	
                                                             III. Investigations and Records                                   method	validation	deviations	and	OOS.
      •	   FDA	proposal	for	validation	in	cGMP	                    •	 Factors	contributing	to	deviations	followed		
                                                                      by	investigations                                        Bonus Material
II. Handling OOS Results and                                       •	 Notes	from	industry                                      •	 An	example	SOP	on	the	online	compendium	
    Protocol Exceptions                                            •	 Handling	investigations	and	CAPAs
      •	 Protocols	and	compilation	of	data
                                                                   •	 Method	transfer	failures	                                Upen Shah, B.S., MBA, Senior Director, Quality Management,
      •	 Reviewing	reports	—	Internal	audits
                                                                   •	 Post	validation	failures	and	QC	life                     Amneal Pharmaceuticals
                10:15     •   N e t w o r k i n g                             a n d            R e f r e s h m e n t                                B r e a k

                    1 0 : 4 5         C h o o s e          B e t w e e n          T h r e e       9 0 - m i n u t e          S e s s i o n s            ( 4 - 6 )

     session 4 •               Acceptance Criteria — Intended Use and Science
Various	definitions	for	test	method	validation	all	          acceptance	criteria	and	challenges	some	of	the	            III. Interactive Exercise
indicate	that	the	method	validation	process	must	            currently	accepted	acceptance	criteria.	                          The	participants	identify	the	intended	use	and	
consider	the	intended	use	of	the	method.			The	
                                                                                                                               appropriate	acceptance	criteria	for	several	
intended	use	of	a	test	method	includes	the	type	of	          I.    Defining the Intended Use
                                                                   •	 When	to	define	and	what	should	be	included               model	test	methods.		Points	of	discussion	are	
a	test	(assay,	identification),	product	specifications	
and	where	the	test	method	is	used	(development	                    •	 Documentation                                            accepted	practices,	compendia	conventions	and	
laboratory,	quality	control	laboratory).			A	general	              •	 Current	practice                                         measurement	uncertainty.
statement	of	the	intended	use	of	a	test	method	can	
be	defined	early	in	the	product	lifecycle	and	should	        II. Establishing Acceptance Criteria                              Jerry Lanese, Ph.D., President,
be	changed	in	a	controlled	manner	as	the	product	                  •	 Identifying	the	characteristics                          The Lanese Group LLC
and	test	method	evolve.			This	session	addresses	the	              •	 Specification	considerations
impact	of	the	intended	use	on	method	characteristic	               •	 Measurement	uncertainty
     Session 5 •              Verification of Compendial Procedures
I.    What Are Compendial Methods?                            • Examples of how to validate/verify                    • How to know when/if to revalidate a
      • Current methods and obstacles                           each characteristic                                     test method
      • Review of terminology                                 • Recent 483s related to validation/verification        • The lifecycle approach to validation
      • Differences between validation and verification         of compendial methods
      • Deciding if you should perform validation                                                                V.   Interactive Exercise
        or verification                                   III. Interactive Exercise                                   Attendees divide into groups of 3-4 people and
      • Relevant references (USP 1225, 1226, 21 CFR           Participants give examples of test methods              select a test method to develop a verification
        § 211.165(e) etc)                                     and describe how they could verify a                    protocol for. Groups focus on the analytical
      • What regulatory expectations are                      specific characteristic.                                performance characteristics (accuracy, precision,
        and how to meet them                                                                                          specificity, etc); determine if each characteristic is
                                                          IV. Validation/Verification —                               required, and if so, devise a plan for how they are
II. Analytical Performance Characteristics                    Putting It All together                                 going to test that characteristic.
      • The 8 analytical characteristics used in
                                                              • What makes a test method validation/
        method validation (accuracy, precision,                                                                       Bonus Material
        specificity, detection limit, quant limit,              verification system compliant
                                                                                                                      • A sample test method protocol template
        linearity, range, robustness)                         • Writing effective test method
      • What terminology is relevant to                         verification documentation                            Anne-Marie Alderson, MBA, Quality Engineering Manager,
        each characteristic?                                  • Handling a failed test method verification            Cook MyoSite Inc.


     Session 6 •              Documenting Method Validation
I.    Importance of Documentation for                     II. Method Validation Protocol and Report              IV. Interactive Exercise
      Method Validation                                       • FDA and other agencies’ requirements                  Using example from FDA inspection
      •   Why are the documents required?                       for validations                                       observations, attendees identify and prepare
      •   Components of method validation documents           • Requirements for submission to FDA                    elements of the validation program.
      •   Writing and importance of protocols                                                                         Upen Shah, B.S., MBA, Senior Director, Quality Management,
                                                          III. Documentation for Compliance                           Amneal Pharmaceuticals
      •   Document requirements during execution              • Making method validation fully compliant
      •   Documenting deviations                              • Rules for documentation
                                                              • Common pitfalls

                                     12:15     •     N e t w o r k i n g                          L u n c h e o n

                        1 : 3 0         C h o o s e       B e t w e e n      T h r e e       9 0 - m i n u t e        S e s s i o n s             ( 7 - 9 )

     Session 7 •             Change Control During Method Development
I.    Requirements for Method Development                     • Various methods for capturing change                  Bonus Material
      Change Control                                          • Learn when to use formal change control               • Guidelines for evaluating method
      • Agency expectations for change control                • Integrating different types of                          development changes
      • Determining when change control is needed               change documentation                                  • Tips for efficient and thorough method
      • Evaluating and capturing change throughout            • Best strategies to document pre-validation              development change control
        the method development process                          change versus post-validation change
                                                                                                                      Alice Krumenaker, ASQ CQPA CMQ/OE, ASQ Certified
      • Preventing overkill when documenting change                                                                   Six Sigma Green Belt, Process Manager, Quality Systems,
      • Creating a change record that complements
                                                          III. Interactive Exercise                                   Merial Ltd.
        your method development process                       Method development examples are provided
                                                              for group analysis and discussion. Participants
II. Options for Method Development                            evaluate the method development change
                                                              control needs and formulate plans for addressing
    Change Control                                            change control in each situation.
      • Determining the appropriate level of
        change control during various stages of
        method development

     Session 8 •              Development and Validation of Analytical Test Methods for Cleaning Samples
This session provides practical approaches to             II. Develop and Validate Analytical                    III. Interactive Exercise
the development of valid methods for analysis of              Method — Keep it Simple                                 Using a real life example, participants study
residual active pharmaceutical ingredients from               • Selecting a residue detection method                  how to develop specific HPLC methods for API
equipment cleaning.                                           • Setting residue limit acceptance criteria             cleaning samples and write a validation protocol.
                                                              • Modifying your release method for analysis of
I.    Select Sampling Procedure                                 cleaning samples                                      Bonus Material
      • When is rinse method applied?                         • Is validation of cleaning analytical method           • Example of validation protocol
      • What solvent to select and how that affects             different from API testing?                           • Relevant articles
        your analysis                                         • Conducting and validating recovery studies
      • When is swabbing method applied?                        from different surfaces                               Rafail Usatinsky, Ph.D., Analytical Research Manager,
      • Learn importance of swabs selection                   • How to check if method validation is required
                                                                                                                      Cedarburg Hauser Pharmaceuticals, Inc.
        based on your method                                    for new products
     Session 9 •             Method Optimization and Validation in the 21st Century
Each participant must bring to the session a fully        III. Getting the Most Out of Your Results                V.   Interactive Exercise
battery charged laptop computer capable of running            •   Hearing the message in the noise cloud                Participants work individually or in small
MS EXCEL. Some previous exposure to experimental              •   Incorporating prior knowledge into predictions        groups to reinforce the concepts learned.
design would be helpful but not necessary.                    •   Dealing with multiple responses                       A simulated method development situation
                                                              •   Finding robustness through                            and simple spreadsheet tool is provided.
I.    Appreciating the Regulatory Environment                     performance simulation
      • Managing risk with ICH Q9                                                                                       David LeBlond, Ph.D., Principal Research Statistician,
      • Knowledge building with ICH Q8                                                                                  Abbott
                                                          IV. Good Strategies for Communicating
      • FDA Process/Method Validation                         Experimental Results
        Guidance perspective
                                                              • Telling the story
II. Awareness of the Win-Win Principles                       • Identifying the ring of ignorance
    Behind Good Experimental Design                           • Describing the inference space and
      •   Incorporating prior knowledge into the model          control strategy
      •   Leveraging hidden replication                       • Communicating the risk
      •   Sequential knowledge building strategies
      •   Reducing variation with interactions

               3:00 •      N e t w o r k i n g                         a n d           R e f r e s h m e n t                                B r e a k

                     3 : 3 0        C h o o s e          B e t w e e n       T h r e e       9 0 - m i n u t e          S e s s i o n s             ( 1 0 - 1 2 )

     Session 10 •             A Practical and Effective Approach to Producing Useful Method Validation Protocols and Reports

I.    Types of Method Validation                          II. Obtaining and Reporting the Data                          Bonus Material
      Protocols/Reports                                       and Conclusions                                           • A method validation procedure
      • The role of risk assessment                           • Using existing data                                     • Templates for method validation protocols
      • Procedure for developing and writing method           • Avoiding repetitive details without                       and reports
        validation protocols                                    losing information                                      • Links to available resources for tools and
      • Supporting documentation —                            • Realistic expectations                                    relevant documents
        SOPs, forms, logs, protocol, training,                                                                          • An example FDA warning letters related to
        method development reports                        III. Interactive Exercise                                       method validation with plans for avoiding them
      • A template for method validation                      Examples of protocol development for various
      • Who approves the method validation and                types of method and process validations are               Sue Mecham, Ph.D., Director of Laboratory Operations,
        what is it based on?                                  explored with respect to the risk assessment              Polymer Solutions Incorporated
      • When does a method have to be re-validated?           determination of critical parameters.



     Session 11 •             Setting Biological Product Specifications
I.    Regulatory Review                                   II. Dosage Form Specific Considerations                  III. Specifications for Other Components
      • Guidances that need to be followed                    • Distinction between quality and                         • Conformance to pharmacopoeial standards
      • Current FDA initiatives relevant to                     performance attributes                                    for excipients
        setting specifications                                • Release versus stability specifications                 • Establishing specifications for
                                                              • Approach for justification of specification               packaging components
                                                              • Differences between biological and small                • Should specifications be specific
                                                                molecule synthetic products                             David T. Lin, Ph.D., Senior Consultant,
                                                                                                                        Biologics Consulting Group, Inc.

     Session 12 •             Tackling the Challenging Development and Validation of Peptide Methods

I.    Introduction to Peptides                            II. Developing Suitable Methods                               • Discerning the differences between
      • What are peptides?                                    for Peptides                                                assay/purity methods for stability trials
      • Discovering the interest in peptides                  •   Methods required for peptide analysis                 • Discover the genesis of common impurities
                                                              •   Example standard USP/EP methods                         in all methods
      • The (sometimes) unique challenges
                                                              •   Transferring in-house of USP/EP methods               • Validating methods that stand the test of time
        developing methods for peptides
      • Looking at USP and EP requirements for                •   Developing methods from scratch
                                                              •   New developments in analytical technology
                                                                                                                   IV. Interactive Exercise
        peptide analysis
                                                                  for peptides                                          Attendees work through example method
      • Learning the differences in analyzing                                                                           development and validation for a peptide,
        peptides and small molecules                                                                                    identifying possible problems and
                                                          III. Validating Peptide Methods
                                                              • Writing clear validation protocols and reports          troubleshooting them.
                                                              • Validating a suitable assay method for                  Claire E. Brook, Ph.D., Senior Research Chemist,
                                                                in-process and/or final product testing                 Covidien

                                         5 : 0 0                  C L O S E              O F          D A Y         T W O
     DAY THREE — MAIN CONFERENCE                                                                                                      FRIDAY, JULY 30, 2010

                                          7:45 •       C o n t i n e n t a l                            B r e a k f a s t

                        8 : 4 5          C h o o s e          B e t w e e n           T w o      9 0 - m i n u t e          S e s s i o n s              ( 1 3 - 1 4 )

     Session 13 •                Use of Statistics for Repeatability, Intermediate Precision and Reproducibility
I.    The Considering Variation                                 III. Determining Intermediate Precision                           • Okay, you found differences — Now what?
      • Where does it come from?                                    •    What are the considerations?
                                                                                                                           V.     Interactive Exercise
      • Understanding variation and its importance                  •    Designing the experiment
                                                                                                                                  The method for determining confounding
      • Developing a statistical sense                              •    One-way analysis of variance                             patterns and new designs for the screening
                                                                    •    Multi-dimension analysis of variance                     method are presented.
II. Determining Repeatability                                       •    Screening studies when things become complex
      •   The standard deviation and error                                                                                        Bonus Material
      •   Which one are you dealing with?                       IV. Determining Reproducibility                                   • A template for the largest experimental
      •   How many replicates?                                      • Designing the experiment                                      design for the screening method
      •   A simple experiment                                       • Comparing multiple results using a simple                   Steven S. Kuwahara, Ph.D., Principal Consultant,
                                                                      analysis of variance
                                                                                                                                  GXP BioTechnology LLC

     Session 14 •                Validation of Chromatographic Test Methods
I.    Chromatographic Methods                                   III. Validation Details                                             • Potential failure modes and risk mitigation —
      Under Consideration                                               • How do you determine the intended purpose?                  Column lot-to-lot variability, dwell volume
                                                                                                                                      in gradient LC methods, poor quality water
      • HPLC, GC and TLC methods in                                     • A successful method development is a                        and reagents
        pharmaceutical analysis                                           prerequisite to a successful method validation
                                                                                                                                    • Example of successful validation and
      • Discussion of methods for assay, impurities                     • Reference standards                                         assay transfer
        and identification of raw materials, in-process,                • Using DOE-based software for
        release and stability samples                                     successful robustness
                                                                                                                            IV. Interactive Exercise
II. Compendial and Regulatory Guidelines                                • Preparing the test solutions, especially
                                                                                                                                    Attendees develop validation strategy and
                                                                          for specificity
      • Key requirements and guidelines from USP                                                                                    experimental design for an HPLC method for assay
        <621> and USP <1225>, ICH (Q1 through Q8)                       • System suitability — How do you identify the              and impurities in a hypothetical drug product.
        documents and FDA guideline documents                             critical pair(s) for the system suitability?
                                                                                                                                    Shreekant Karmarkar, Ph.D., Senior Research Scientist,
      • Validation elements for assay, ID and                                                                                       Global R&D, Baxter Healthcare
        impurities methods
               10:15     •     N e t w o r k i n g                              a n d           R e f r e s h m e n t                                 B r e a k

                       1 0 : 4 5          C h o o s e           B e t w e e n          T w o      9 0 - m i n u t e             S e s s i o n s            ( 1 5 - 1 6 )

     Session 15 •                Six Sigma Applications in Method Validation
I.    Six Sigma Introduction                                    III. Six Sigma in Method Development                       IV. Interactive Exercise
      •   Six Sigma background                                       and Validation                                               Participants are given of Six Sigma tools that
      •   Overview of Six Sigma tools                               • Six Sigma tools for method development                      may be incorporated into method development
      •   Roles of Black and Green Belts                            • How Six Sigma in method development can                     and validation, select Six Sigma tools and
      •   Pros and cons to using Six Sigma                            help in method validation                                   plan implementation strategies for method
      •   Value of using Six Sigma in the lab                       • Implementing Six Sigma in method                            development/validation scenarios.
                                                                      development and validation                                  Bonus Material
II. Six Sigma in the Lab                                            • Role of Six Sigma in method validation
      •   What are uses for Six Sigma in the lab?                                                                                 • List of Six Sigma Tools
                                                                    • Benefits to using Six Sigma in method                       • Links to Six Sigma information
      •   Is a formal project necessary?                              development and validation
      •   Implementing Six Sigma in the lab                                                                                       • Tips for using Six Sigma in the lab
      •   Integrating Six Sigma into existing lab processes                                                                       Alice Krumenaker, ASQ CQPA CMQ/OE, ASQ Certified Six Sigma
      •   Overcoming opposition to Six Sigma                                                                                      Green Belt, Process Manager, Quality Systems, Merial Ltd.

     Session 16 •                How to Conduct the Method Validation with a New IPT (In-Process Testing) Method
I.    Overview of Method Validation and IPT                       III. Method Validation in This Study                            IV. Interactive Exercise
      •   Elements of method validation                                   • Design validation experiments                               Participants discuss the challenges in
      •   Challenges in IPT — Dynamic data                                • Implementation of validation protocol and                   the real world of method validation and
      •   Application of cross-validation techniques                        sample collection                                           share solutions.
      •   Accounting for human factors variance                           • Data analysis                                         Weifeng “Frank” Zhang, Master of Engineering,
                                                                          • Statistical approach                                  Validation Manager, Medarex BMS
II. How to Verify the New Method Is the                                   • Use “Hypothesis Testing”, “ANOVA” and
    Same as the Existing One                                                                                                      Ernest Lee, Master of Science, Senior Manager
                                                                            “Advanced Techniques” to prove the new                Facilities and Engineering, Medarex BMS
      • What if there is no “golden standard” to compare                    method has no significant difference with
        the testing results from two methods?                               respect to existing method
      • Identify validation acceptance criteria
      • Difficulties when the testing instrument is different

                                    1 2 : 1 5                    C L O S E                 O F         C O N F E R E N C E
           R e g i s t e r b y M a y 2 1 , 2 0 1 0 a n d R e c e i v e $ 2 0 0 O f f o f Yo u r R e g i s t r a t i o n F e e !

                                   IVT’s 7th ANNUAL                                                                                         Build a Method Validation
                                                                                                                                         roadmap for Your organization:

 Method                                                                                                                                • Know Fda and global Regulatory Requirements



  Validation
                                                                                                                                       • Transfer a method Cross Functions
                                                                                                                                       • utilize Qbd Concepts to design and Perform
                                                                                                                                         method validation

    designing Quality in Methods                                                                                                       • use statistics for Repeatability, intermediate Precision
                                                                                                                                         and Reproducibility
     that Survive the lifecycle                                                                                                        • set biological Product specifications
                                                                                                                                       • Know the impact of intended use on acceptance Criteria
                  July 28-30, 2010
    Sir Francis Drake Hotel • San Francisco, CA                                                                                        • understand the impact of Fda’s new Process validation
                                                                                                                                         guidance on method valiation


     The Next Best Thing to Being There…                                                         CBI
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