Thursday, October 5

7:30 Registration and Morning Coffee

8:15 Chairperson’s Opening Remarks
Dr. Alex D. Kanarek, President, Bio-Development Consulting Services

 

Featured Presentation:

The Quality System, Process Validation and GMP Compliance Dr. Alex D. Kanarek, President, Bio-Development Consulting Services The latest guidances from FDA and ICH are emphasizing the need to establish full Quality Management Systems in GMP facilities. This paper will analyze the essential functions of a QS, the way to set it up, and how its operation can be integrated into the Quality Assurance function of a small pharma or biopharma company. The talk will also include a discussion on new concepts in process validation and control, including process analytical technology (PAT) and risk management, and how these may affect process development and operation.

9:10 Regulatory Compliant Research
Mr. Patrick DeVillier, M.S., Senior Director, Compliance, A.P. Pharma Inc.
Why does one bring together the development processes of research and development with the manufacturing processes conducted in compliance with the cGMPs? The answer is that it is a component, and arguably a requirement, of the life cycle of a product. We will review the foundational units of regulatory compliant research and demonstrate through case studies how regulatory compliant research effectively and efficiently threads R&D to regulatory submissions in a manner that allows product-related activities to not only meet the requirements of scientific soundness and regulatory review, but in addition, meet the needs of the corporate financial allowances.

9:50 GMP Compliance During Product Development
Dr. Lee McDonald, Manager, Manufacturing QA, Clinical Research, Memorial Sloan-Kettering Cancer Center
During clinical development, GMPs are intended to be applied on a sliding scale of rigor, acknowledging the research nature of the product. And in a draft guidance of this year, the FDA proposed that production for phase 1 studies need not comply with 21CFR part 211. Time and cost savings are possible if an organization is flexible enough to match their manufacturing compliance practices to the phase of product development. Quality management principles and R&D-phase standards for GMP compliance will be presented, which will be useful for development-phase companies, academic medical centers, as well as commercial drug makers.

10:30 Networking Coffee Break

11:10 Going Paperless in cGMP Operations using a GMP Electronic Notebook System Impacts on QC Laboratories and Production Batch Record Management
Mr. John P. Helfrich, Director, GMP Automation Programs, VelQuest Corporation
Leading companies are adopting a new approach to automating the non-value added tasks associated with paper processes in QC and batch record management. The dominate strategy is utilizing innovative technologies (such as Electronic Notebooks) and building quality into the research, quality and compliance infrastructure. 
The paper will discuss the current situation in cGMP lab operations relative to FDA initiatives in manufacturing and the broad opportunity for electronic lab notebook processes. The paper will profile an innovative “method-centric” software platform, designed to electronically execute and manage laboratory protocols, and production batch records, yielding significant reductions in overall method execution cycle times and electronically capture all data and metadata in a common repository. This technology can be defined as PAT (process analytical technology) for QC laboratory processes.

11:50 Quality Management
Mr. Joe Czwiertniewicz, Principal, Quality and Regulatory Compliance

1:10 Lunch on Your Own (Sponsorship Available)

2:30 Root Cause Investigation and CAPA
Mr. Wade Speir, Practice Leader, Life Sciences Kepner-Tregoe, Inc.
Learn to conduct robust root cause analyses on unexpected deviations using lab, manufacturing and quality data to clearly document investigations to prevent FDA 483s, inspection findings, and warning letters. This presentation will present a systematic four step process to find root cause. First, describe the problem with a clear, complete problem statement and specification. Second, identify possible causes using both knowledge and experience as well as distinctions and changes. Third, evaluate possible causes by testing them against the problem specification to determine the most probable cause. Finally, confirm the true cause by verifying assumptions, observing, experimenting, fixing, and monitoring. 

3:10 GMP and FDA Compliance 
Mr. Arthur N. Levine, Partner, Arnold & Porter LLP
Recent FDA cleaning and cleaning validation related observations and comments indicate continued scrutiny in this area. The materials presented include cleaning related comments by FDA inspectors and compliance officers, recent pre-inspection questions, and 483’s and warning letters from manufacturing facilities. Specific topics to be discussed include review of latest FDA inspection methodologies with respect to cleaning, assessment of trends in cleaning related 483’s and warning letters, risk analyses as related to cleaning and FDA expectations, and review of FDA expectations for training, especially with respect to manual cleaning.

3:50 Networking Refreshment Break

4:20 Cleaning Compliance Points to Consider: Recent Areas of Regulatory Agency Comment
Mr. John Hyde, President, JM Hyde Consulting, Inc.
How FDA gathers evidence of potential cGMP noncompliance, how FDA assesses that evidence, and how FDA deals with significant noncompliance will be addressed. It will be discussed how companies can prepare for FDA review of their cGMPs and how they can respond to FDA if FDA expresses concern about a company's cGMP compliance. Challenges in maintaining and sustaining cGMP compliance will be identified. Furthermore, FDA's initiatives to encourage companies to increase their use of risk assessment techniques in developing and challenging their quality systems will be discussed.

5:00 GLPs for the cGMP Auditor
Mr. Jim Carignan, RQAP- GLP, Chiron Corp.

5:40 End of Day One