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Guidance for Industry: “…tools of quality risk management that can enable more effective and consistent risk-
based decisions, by both regulators and industry …”
Strategies to Effectively Apply
Q9 QUALITY RISK REGISTETH 3
and th
R
e 4 is
FREE!
MANAGEMENT
in the FDA Regulated Industry
WYETH
TUDY Tools, Techniques and Experiences in Utilizing Q9 Quality Risk
CASE S
ADDED Management for Enhanced Efficiencies and Regulatory Compliance
June 4-5, 2007 • La Jolla Marriott • San Diego, CA
LEARN FROM THE EXPERIENCE OF INDUSTRY EXPERTS!
ELI LILLY AND COMPANY JOHNSON & JOHNSON
Managing Qualification Risk
Risk-Based Validation by the Numbers
by Using Commissioning
10 INDUSTRY
CASE STUDIES
ARENA PHARMACEUTICALS and
INCLUDED
FIRST QUALITY INC. WYETH
WORKSHOP Risk-Based Computer System Applications of Risk Management Tools
Assessments - the Inspector Cometh
NETWORK WITH
THE EXPERTS
COMPUTER SYSTEMS
HPFM INC. VALIDATION
Using Risk to Reduce Validation Costs Achieving Cost-reduction Without
Increasing Regulatory or Business Risks
PHARMACEUTICAL SERVICES DRUMBEAT DIMENSIONS, INC.
CORPORATION Implementing a Risk
Applying the Risk Based Approach to
Management Program
Computer Systems Validation
…..AND MANY MORE
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Organized By: SWE Enterprises • P.O. Box 23202 • Tampa, Florida 33623
Telephone: 813-655-7788 • Fax: 413-480-9953 • Website: www.sweinc.biz 1
FDA Warning Letter Excerpt “…risk is defined as the combination of the probability of
occurrence of harm and the severity of that harm...”
DAY ONE their 21CFR Part 11 training and audit team. Now in private
MONDAY, JUNE 4, 2007 practice as a quality consultant, he also lectures at UCSD in
validation and has presented or chaired public seminars on
7:45 REGISTRATION AND BREAKFAST cGMP Requirements, Computer System Validation, Analytical
Methods Validation and Infrastructure Qualification.
8:45 CHAIRPERSON’S WELCOME AND
James Nelson is the Director of Quality Assurance at Arena
OPENING REMARKS
Pharmaceuticals; a San Diego based Biopharmaceutical
Company. He oversees the Quality function working directly
IN-DEPTH INTERACTIVE WORKSHOP with manufacturing to help produce an integrated Quality
throughout the firm. James oversees Quality from manufacture
CASE STUDY of API through production of final drug product for multiple
stages of clinical development. Additionally, James has been
9:00 RISK-BASED COMPUTER SYSTEM instrumental in building Quality and ensuring that Quality
ASSESSMENTS – THE INSPECTOR COMETH Systems are capably of adhering to client and regulatory
James Nelson, Director QA expectations throughout the development lifecycle. James
ARENA PHARMACEUTICALS previously served as Director of QA/QC for SERES
Laboratories which is a contract manufacturing organization
Rich Poser, President
(CMO) in the San Francisco Bay Area. James has hosted
FIRST QUALITY INC. hundreds of audits from clients as well as regulatory agency
inspections. Additionally, he performs external audits for Arena
The most recent revision to 21CFR Part 11 emphasizes the use Pharmaceuticals both within the United States and
of Risk Management in computer system validation. We will Internationally. James holds two bachelors’ degrees in
discuss a process by which pharmaceutical, biotech, medical Chemistry and Biology as well as numerous certifications is
device and other regulated manufacturing companies can assure Quality and Auditing.
their systems are implemented and operated in compliance, and
how to prepare for regulatory inspection. In a session including
12:00 LUNCHEON
both lecture and hands-on workshop activities, the participants
will learn how successful companies inventory, assessed risk,
prioritized remediation and operate their systems in compliance. CASE STUDY
You will learn a proven methodology that has produced "no
observation" regulatory inspections. A case study will be 1:00 MANAGING QUALIFICATION RISK BY
included by a corporate sponsor showing the actual manpower USING COMMISSIONING
effort required, deliverables produced and inspection comments. Blaik C Jensen, Senior Quality Assurance Engineer
Sample forms and worksheets will be provided, and participants ELI LILLY AND COMPANY
will use their own real-life examples as training tools.
The requirements of equipment qualification in the
About the workshop leaders: Rich Poser, Ph.D is President of pharmaceutical industry cause companies either to accept
First Quality Inc., a quality consulting firm focused on Quality capital project cost and schedule over-runs due to utility and
Systems, Training and Validation. Their clients include equipment qualification as an unavoidable cost of doing
biotechnology, pharmaceutical and medical device manufacturers, business, or to pre-empt the cost and time commitments by
as well as the vendors such as contract laboratories, instrument installing and using their utility systems or equipment, but not
manufacturers, contract manufacturing sites and software qualifying them (with dire consequences).
developers that support these highly regulated industries. He
obtained his Masters and Doctorate degrees in Medical This case study will present project concepts, execution strategies
Sciences at New York University Medical, Graduate School of and documentation guidelines that successfully leveraged
Arts & Science in his home town of New York City, and equipment commissioning to manage the risk of qualification.
completed a PHS Fellowship at Sloan-Kettering Institute. Rich
was initially Director of Analytical Sciences and later Director Eli Lilly and Company recently completed a Pilot Plant facility
of Information Systems for Fisons Pharmaceuticals. Following for the manufacture of Clinical Trial material. Out of the over
work in product development, laboratory automation, validation 200 facility systems, all were commissioned and more than
and laboratory quality systems for the Mylan Pharmaceutical 90% were qualified. Manufacturing operations started in the
Company, Rich joined Dura Pharmaceuticals in San Diego as facility on schedule. Though project cost was not under budget,
Analytical Laboratory Director and Director of R&D Quality total project cost percentage was much less than similar capital
Assurance. Following acquisition of Dura by Élan, Rich was projects at Lilly. Three product campaigns have been completed
appointed Director of Quality Laboratory Operations and led flawlessly in the new pilot plant.
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APPLICATION OF RISK MANAGEMENT requirements with the need for cost-effective validation. The
TO VALIDATION different validation needs of various types of computer systems
will be discussed. Methods for effective documentation of
CASE STUDY activities will be discussed. This session will cover what you
need to know to be prepared for a regulatory review of your
2:00 USING RISK TO REDUCE CSV program.
VALIDATION COSTS
Attendees will learn as part of this session:
Chris Potter, Vice President
HPFM INC. • Learn how to structure a CSV program that is meaningful
for your company’s IS investment
The FDA has issued guidelines that suggest we should work
smarter not harder. This presentation will discuss how a risk • Be prepared to configure your validation program to your
management approach can leverage vendor work and reduce company’s needs
validation costs. This session should answer: • Learn methods for Risk Assessment that will meet your
• How can you leverage vendor work on a COTS system? business and regulatory requirements
• How can risk management allow you to "focus" • Learn how to coordinate the multi-disciplinary efforts
your testing? needed to complete a successful information systems
validation
• How do you determine what testing is required?
3:00 AFTERNOON BREAK AND REFRESHMENTS 5:15 INTERACTIVE PANEL DISCUSSION
CASE STUDY INCLUDING ALL DAY ONE SPEAKERS
• Observations and direction
3:15 RISK-BASED VALIDATION BY THE
NUMBERS • Trends in new technologies
William Honeck, Associate Director QA Validation • Lessons learned from utilizing Q9 quality risk
JOHNSON & JOHNSON PHARMACEUTICAL R&D management effectively
Rich Poser, President • Questions and answers
FIRST QUALITY INC.
5:45 END OF DAY ONE
While much has been written about performing Risk-Based
Validation, there are few practical examples of what this really
means. This talk will illustrate how an arithmetic model of risk
assessment was utilized in relocating an operating QC Stability DAY TWO
Management and Analytical Laboratory Unit to a new facility. TUESDAY, JUNE 5, 2007
This tool was applied to all new or relocated systems, facility
components, manufacturing and test equipment and enabled the 7:30 BREAKFAST
company to efficiently determining the correct validation
standards for each item. This enabled a highly compliant and
8:25 CHAIRPERSON’S OPENING REMARKS
cost-effective utilization of resources to complete the project in
a timely fashion.
ADDED INDUSTRY SESSION
CASE STUDY
CASE STUDY
4:15 APPLYING THE RISK BASED APPROACH
8:30 APPLICATIONS OF RISK
TO COMPUTER SYSTEMS VALIDATION
MANAGEMENT TOOLS
John LaMascus, Senior Project Manager
John A. Shaeffer
PHARMACEUTICAL SERVICES CORPORATION
WYETH
This session will address a summary review of the FDA’s
The presentation provides a brief overview of selected risk
current guidelines on Risk Management and how to apply them
management tools listed in ICH Q9. Additionally, risk
in a meaningful way to your CSV program. This session will
management tools not mentioned in ICH Q9 and applicable
address the recommended risk management tools, methods and
case studies for selected tools will be reviewed and discussed.
procedures and ensure that you can balance regulatory
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This session will examine: • Scoring the risk to prioritize remediation
• Translating risks into actionable remediation
• Brief overview of selected risk management tools
• Managing remediation across organizational channels
listed in ICH Q9
• Precluding risk with EBC® "Effect Based Compliance"
• Brief overview of additional risk management tools not
analysis
listed in ICH Q9
• Case studies for selected risk management tools
12:00 LUNCHEON
• Potential applications of risk management tools
• 20 years of lessons learned implementing risk management CASE STUDY
tools from other industries
IN-DEPTH SESSION ON BUSINESS AND
CASE STUDY REGULATORY BENEFITS OF RISK MANAGEMENT
9:45 IMPLEMENTING A RISK 1:00 ACHIEVING COST-REDUCTION
MANAGEMENT PROGRAM WITHOUT INCREASING REGULATORY
OR BUSINESS RISKS
Tim Fields, President
David Nettleton, Senior Manager
DRUMBEAT DIMENSIONS, INC.
COMPUTER SYSTEM VALIDATION
This presentation will explore the implementation of a Risk
Achieve better productivity and quality with efficient validation
Management System in a pharmaceutical environment using the
methods:
processes defined in ICH Q9. The presentation will review the
regulatory perspective, the risk management process, some risk • How to increase corporate productivity, and individual
management tools, techniques, and terminology, and the risks workforce member productivity
and benefits to implementing a risk management program. • How to efficiently create validation documentation
10:30 MID-MORNING BREAK • How to determine risk in a process
CASE STUDY • How to write test cases that trace to elements of
risk management
10:45 APPLICATIONS OF RISK ASSESSMENTS • How to significantly lower costs and reduce software
Ralph L. Dillon, Director implementation times
COMPLIANCE SURETY ASSOCIATES
2:45 AFTERNOON BREAK
Risk Assessment is a broad term used by different industries
and variable disciplines to identify and rank many threats of CASE STUDY
variable intensity. Rationally insurers and underwriters typically
break down their analyses into different levels of analysis to 3:00 SUCCESSFUL APPLICATION OF RISK
roughly follow business responsibility. They focus to business
MANAGEMENT TO PRE-APPROVAL
threats and freedom to operate and generally cascade from
INSPECTIONS
"Financial Level Risk to "Market Level Risk" to "Product Level
Risk" and finally, "Plant Level Risk". Joseph F. Noferi, Director
COMPLIANCE SURETY ASSOCIATES
ICH Q9 formally brings Risk Assessment into a codified
requirement for "compliance" with FDA regulations, drawing Regulatory approval of a new drug product challenges everyone
upon well established techniques that cross industries and in the organization. The directive from high up is simply
endeavors. The FDA inspectorate necessarily focuses on the stated - bring the product to market but at the operational levels
products they regulate and the plants that make them, i.e., where directives must be translated into actions, challenges
"Product Level Risk" and "Plant Level Risk". abound. Delivering a clear regulatory outcome in an indefinable
regulatory landscape is a daunting task that that requires an
This presentation focuses on proven methodologies and tools amalgamation of knowledge, experience, expert judgment and
for risk assessment that have been used by the presenter to serendipitous timing. Nowhere is this more poignant than to those
successfully remediate standing FDA warning letters and afford that must integrate and often optimize the efforts of so many
proactive strategies for new products undergoing Pre-Approval others under the mantle of regulation and face the metric of a Pre-
Inspection (PAI). approval Inspection. For example, Co-developed/co-manufactured
products, Biopharmaceutical products, and products bridging
• Organizing/Scoping a Risk Assessment multiple regulatory divisons (such as device + drug) take this
• Performing the Risk Assessment several levels higher and add multiple layers of complexities. It
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becomes even more problematic when the facility is new or
recently re-fitted. Highly technical manufacturing processes and
specialized controls must be matched with specialized analytical
methods - and process and analytical changes continue, and will
likely continue well into the post-inspection launch. Rarely are
these capabilities centralized or even co-located and, even then,
the data generated must be integrated into a presentable and
comprehensible format. To assure success, this integration of data
should be done using EBC® “Effect Based Compliance”
principles to encourage the desired outcome, rather than merely
catalog the work done to date.
This presentation will present case study examples of Pre-
Approval preparations to overcome the challenges which must
surpassed to achieve marketing approval. Both Field and Center
expectations will be highlighted.
• Origin and status of Regulations
• The development program
• The application – BLA/NDA
• The product is the process
• The facility
• Roles and responsibilities
4:15 END OF CONFERENCE
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STRATEGIES TO EFFECTIVELY APPLY
Q9 QUALITY RISK MANAGEMENT
SWE ENTERPRISES, Inc.
Pharmaceutical Conference Division IN THE FDA REGULATED INDUSTRY
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