Get documents about "Method Validation Template - PDF
W
Description
Method Validation Template document sample
Document Sample
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
600 Unicorn Park Drive • Woburn, MA 01801
PRSRT STD
U.S. Postage
Order the Online Compendium if you would like to capture what you’ve missed PAID
at the conference. It couldn’t be easier. The link to the online compendium is Gallery
available for only $198 and includes the conference agenda, presentations and
speakers’ biographies. Don’t miss out on this valuable information presented
by industry leaders exclusively at this event. Simply fill out the order form
and submit via phone, fax or website and you’ll receive the link to the
Online Compendium within 2 weeks after the conference.
• Registration Fee: Standard Advantage Pricing
3-Day Conference $2,495 $2,295
Advantage Pricing — Register by May 21, 2010 and SAVE $200.
Fee includes continental breakfast, lunch, wine and cheese reception, refreshments
and Online Compendium. Please make checks (in U.S. funds drawn on a U.S. bank)
payable to CBI Research, Inc. (No personal checks accepted) Advantage Pricing may
Registration Card DO NOT REMOVE MAILING LABEL. PLEASE RETURN ENTIRE FORM. PI10081
not be combined with other discount offers, special category rates or promotions.
Wednesday, July 28, 2010 1:30PM – 3:00PM ◯7 ◯8 ◯9
Discounts only apply to standard rates.
1:30PM – 5:00PM ◯a ◯B ◯C 3:30PM – 5:00PM ◯ 10 ◯ 11 ◯ 12
• Team Discount: thursday, July 29, 2010 friday, July 30, 2010
Your organization may send 1 executive fRee for every 3 delegates registered. 8:45AM – 10:00AM ◯ 1 ◯2 ◯3 8:45AM – 10:00AM ◯ 13 ◯ 14
All registrations must be made at the same time to qualify. 10:45AM – 12:15PM ◯ 4 ◯5 ◯6 10:45AM – 12:15PM ◯ 15 ◯ 16
• Accommodations: ChOOSE EVENT OPTION
To receive CBI’s special discounted hotel rate on line or by phone, please go to: ◯ I cannot attend. Please send me a Conference
◯ 3-DAY CONFERENCE Online Compendium.
• On-line: www.ivtevents.com/methodval (before May 21, 2010) ............................................. $2,295
Do you have any special needs? _________________________
• Phone reservations: 800-227-5480 and mention IVT’s Method Validation ◯ 3-DAY CONFERENCE (after May 21, 2010) ................ $2,495
Conference. KEY CODE
◯ We would like to take advantage of the TEAM DISCOUNT
Cut-off date is July 13, 2010. Reservations made after the cut-off date or (see left for details). (appears above mailing address): _________________________
after group room block has been filled (whichever comes first) will be accepted
on a space and rate availability basis. Rooms are limited so please book early. 1. NAME POSITION
All travel arrangements are subject to availability. Register 3
Get 1 FREE
• Venue: 2. NAME POSITION
Sir Francis Drake hotel 3. NAME POSITION
450 Powell Street • San Francisco, CA 94102
hotel reservations: 800-227-5480 4. NAME POSITION
hotel direct line: 415-392-7755 Free
• Substitution & Cancellation: COMPANY DIVISION
Your registration may be transferred to a member of your organization up to
ADDRESS
24 hours in advance of the conference. Cancellations received in writing on or before
July 14, 2010 will be refunded, less a $195 administrative charge. No refunds CITY STATE/COUNTRY ZIP/POSTAL CODE
will be made after this date; however, the registration fee less the $195 administrative
charge can be credited to another CBI conference if you register within 30 days from TELEPhONE FAX E-MAIL
the date of this conference. In case of conference cancellation,
CBI’s liability is limited to refund of the conference registration fee only. AUThORIZED SIGNATURE
CBI reserves the right to alter this program without prior notice.
Please Note: Speakers and agenda are subject to change without notice. Payment Options: Payment in full is required to process registration. Please call with any payment questions.
In the event of a speaker cancellation, every effort to find a suitable replacement will Enclosed is a check for payment in full (No personal checks accepted) Please
be made. The opinions of the conference faculty do not necessarily reflect those of the photocopy
companies they represent or The Center for Business Intelligence. MC/Visa: this form for
additional
• Satisfaction Guaranteed: Amex: delegates.
CBI stands behind the quality of its conferences. If you are not satisfied with the
quality of the conference, a credit will be awarded towards a comparable NAME (AS APPEARS ON CARD) EXP. DATE
CBI conference of your choice. Please contact 800-817-8601 for further information.
Advanced preparation for CBI conferences is not required. CARDhOLDER SIGNATURE
WeBSiTe Phone fAX e-MAil MAil
5 Easy Ways www.
ivtevents.com/
800-817-8601 781-939-2490 cbireg@cbinet.com CBI Registration Dept.
339-298-2100 Please include all information 600 Unicorn Park Drive
to REgistER methodval
outside the U.S. requested on registration card. Woburn, MA 01801
Related docs
Other docs by vrl99833
Operational Recycling Centers updated 2 24 2011 Department of Resources Recycling and Recovery CalRecycle Division of Permitting and Certification County City Cert Num
Views: 189 | Downloads: 0
