Expert Presentations

Tuesday, 9 December 2003 - 21 CFR 11 Compliance

Developing a Remediation Plan for Part 11 Compliance
Mark Best, Advanced Automation Associates, Inc.

How do you approach the problem of upgrading your control and information systems to Part 11 compliance? This presentation will look at strategies for remediation of existing systems that fall under the regulation. The remediation planning process is broken down into project phases and their associated documents. The presentation will provide a roadmap to create a documented action plan that includes anticipated costs, resources, and schedules.

Mark Best is a validation specialist with Advanced Automation Associates, Inc. and a vice-president of the ISA's Philadelphia Section. Mark has 18 years of experience in control systems integration covering specification, design, implementation, testing, validation and project management of computer-based control and information systems. He has concentrated on pharmaceutical applications and validation of computerized systems for the last 12 years. Mark has authored documents ranging from project proposals to validation reports for numerous pharmaceutical manufacturers’ projects, including plant-wide Part 11 remediation planning.

Implementations that work for Part 11 Compliance
Jim Kandler, Medical Software, Inc.

You have learned the regulations, and have heard about the companies receiving 483's.  The regulations don’t tell you any thing about what to do to become compliant.  The 483's are vague about what they actually found wrong.  So what implementations actually work?  The presenter has implemented several systems that have been shown to be compliant to 21 CFR Part 11.  This presentation will provide implementation details that you could use for implementing compliant systems.  

Jim Kandler is a Principal Consultant with Medical Software, Inc.  Jim has 16 years experience inside of the medical device companies.  He has experience in the development, implementation, and validation of internal quality IT systems and medical products.  Jim holds 2 certifications (CSTE, CSQE), has presented at several international conferences and currently teaches at Marquette University.

Re-Building Your Compliance Program to Capitalizes on Risk Management
Steve Thompson, Amgen

FDA's new risk management initiative, introduced February 2003, provides a solid foundation that companies can use to build an effective, practical 21 CFR Part 11 compliance program. When Part 11 was introduced in August of 1997, many companies tried to comply. However, Part 11 was left to interpretation, which took companies down several roads. One road was insufficient; the other was excessive. Only the fortunate few actually achieved the middle ground that was "just right." So as the Part 11 pendulum swung from one extreme to the other, FDA's new risk management initiative helps center the pendulum and allow companies the ability to utilize technology tools to advance their scientific endeavors. What is important now is for organizations to gain an understanding of this methodology and establish a program that will capitalize on the benefits that risk management can deliver to them.

Risk Analysis: How to Use Risk Assessment for 21 CFR Part 11 Compliance
Victoria Lander, NuGenesis Technologies

The new FDA Draft Guidance Document discussing the revised scope and applicability of 21 CFR Part 11 clearly adopts a risk-based approach to Part 11 compliance. This is certainly a very pragmatic approach and one that many regulated firms had adopted even before the recent release of this document. The favored risk assessment protocols such as HACCP, FMEA and FMECA will also be addressed as well as:

• Discussion of the new FDA Draft Guidance Document for Part11 interpretation
• Why do a risk assessment?
• What are the commonly industry accepted risk management approaches?
• How to apply HACCP, FMEA and FMECA to risk assessment for Part 11
• Moving forward with your Part 11 remediation plan

Victoria Lander is currently a Market Development Manager at NuGenesis Technologies Corporation (Westboro, MA). She is responsible for marketing and market development for NuGenesis software products focused on the pharmaceutical industry. Victoria also sits on the PDA 21 CFR Part 11 Task Group (adjourned) in Bethesda, MD, and has given many conference presentations on Part 11. Victoria was the Sr. Marketing Manager for Applied Biosystems in Framingham MA where she managed a group responsible for the promotion and tactical marketing of LC/MS products from Applied Biosystems/MDS SCIEX. She was previously the LC/MS Marketing Manager at Waters Corporation (Milford, MA) for the Integrity and Alliance LC/MS AMD System products. Prior to this position, she was a Field Sales Representative for Waters in the New Jersey area.  Victoria’s past experience includes a position as a Field Marketing Chemist for Varian Associates for the Saturn GC/MS product line, Instructor at the Finnigan MAT Institute in Cincinnati and various research positions in mass spectrometry including those at the University of Arizona, Hoffmann LaRoche in Nutley, NJ and at the Mount Sinai Medical Center in NYC.  Earlier biomedical research positions were also held at The Burke Rehabilitation Center in White Plains, NY and at American Cyanamid in Stamford, CT.

Victoria has a BS in Biology and a BA in Psychology from Purdue University, graduate credits from Long Island University and 27 total publications in the biology and biochemistry-related fields.

The Role of Biometrics in 21 CFR Part 11
Cliff Kittle, SAFLINK Corp.

21 CFR Part 11 was created for the purpose of defining how product design and manufacturing electronic records and electronic signatures are controlled. Recent events have heightened the concern regarding network, information, and intellectual property security and these concerns are partly addressed in Part 11. A study performed by the American Society for Information Security and Price Waterhouse pointed out the fact that Fortune 1000 companies lost $45B in intellectual property in 1999. A majority of this lost intellectual property was in the manufacturing process and R&D segments of the corporations. While biometric technology for authentication is not the complete answer to the problem, it is an integral part of the total solution. We will discuss where and how it fits in a corporate security solution. This presentation will address the technical and business benefits of biometric technology authentication in achieving the Part 11 requirements.

Where's Part 11 Heading?
Dr. Raymond Miller, Miller Regulatory Consulting, Inc.

The FDA has yet again re-issued the Part 11 Guidances. Systems that provide electronic records/electronic signatures for predicate rule records must still comply. Given the most recent interpretation, Dr. Miller will present some recommendations for moving forward while minimizing the impact that future Part 11 revisions might require. Dr. Miller earned a Ph.D. in analytical instrumentation from the University of Cincinnati and has attended the Graduate School of Business at Stanford University. He is a frequent lecturer on 21 CFR Part 11 and Computer Systems Validation regulatory compliance.

Wednesday, 10 December 2003 - GMP Compliance

Improving Quality By Means of New Process Initiatives in the Pharmaceutical Arena
Victoria Lander, NuGenesis Technologies

The FDA and the pharmaceutical and biotech industries have a common objective: protecting product quality and public safety. With that in mind, there is renewed emphasis for all parties on a risk-based approach to managing development and manufacturing in the pharma arena. The goal is to create and thoroughly document a pragmatic process by which regulatory compliance initiatives can be prioritized while still maintaining overall productivity. This presentation discusses the new FDA risk-based approach to cGMPs for the 21st Century and some of the quality enhancement processes that have stemmed from this Agency initiative. The new Process Analytical Technology (PAT), the Cooperative Research and Development Agreement (CRADA) and the working industry definitions of Quality will also be addressed.

Preparing for GMP Audits
Dennis Brandl, BR&L Consulting

Preparing for a GMP audit is vital to successfully completing the audit. Even though the recent FDA guidance on 21 CFR Part 11 makes it less encompassing, many systems which do not need to comply with 21 CFR Part 11 still need to be validated. Validation is one of the main elements covered by a GMP audit, and it is important to understand what will be asked of you, the role of the auditor, your role, and the role of your co-workers. Auditors are responsible for maintaining control of an audit, and being diplomatic but not conciliatory. They define the purpose, set the agenda and maintain the audit's focus, allowing you and your co-workers to do much of the talking. This session will discuss what to expect in an audit, including techniques used by auditors to discover information.

Risk Analysis Demonstrated
Jim Kandler, Medical Software, Inc.

GAMP 4 has used and now the FDA is talking more about Risk Analysis.  Some people are suggesting that we can use this to focus our quality efforts and reduce costs.  The GAMP manual explains Risk Analysis in all of 12 pages.  So how do I actually perform a Risk Analysis?  What traps should I be aware of?  This presentation will review that GAMP process and demonstrate the process step by step for those new to Risk Analysis.

Use of the V-Model and Variations from GAMP 4 for Process Controls Systems
Raymond Miller, Miller Regulatory Consulting, Inc.

The FDA has indicated that no one system development life cycle methodology will fit every system, and that regulated companies are free to use any methodology that allows them to meet Federal regulations. GAMP 4 includes several variations on the V-Model that can be used for automated system projects. This presentation reviews the relevant GAMP models and describes how they can be applied to a range of PLC and SCADA projects.