First Annual CAPA Congress Agenda
DAY ONE Wednesday, Dec. 2 |
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8:30 a.m. – 9:30 a.m. |
Registration and
Continental Breakfast |
9:30 a.m. – 9:45 a.m. |
Welcome and
Introduction |
9:45 a.m. – 10:45 a.m. |
CAPA Compliance Outlook: New Enforcement Priorities A top CDER official discusses recent increases in CAPA systems scrutiny ... how the FDA is addressing CAPA concerns ... and what stepped-up enforcement will mean for drug and biologics manufacturers.
Edwin Rivera-Martinez, Chief, Manufacturing Assessment and Preapproval, Compliance Branch, Division of Manufacturing & Product Quality, Office of Compliance, CDER, FDA (invited) |
10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 11:45 a.m. |
Boehringer Ingel-heim Case Study: Process Improvement Teams Create a Strong CAPA Program Top-quality QA management and oversight is the key to effective CAPA system management and case closure. Learn how Boehringer Ingelheim’s QA department created a Process Improvement Team (“PIT Team”) that separates specific quality issues from systematic ones and seeks practical solutions via application of risk management principles. You’ll discover:
Kenneth Wexler, Senior Quality Assurance Compliance Analyst, Boehringer Ingelheim Pharmaceuticals |
11:45 a.m. – 12:30 p.m. |
Forest Research Institute Case Study: Integrating Pharmacovigilance Into Quality Management Systems Forest’s drug safety surveillance procedures are set up to track the resolution of each noncompliant incident throughout all business activities. Discover how this firm integrates pharmacovigilance into the QA system, while handling process-related issues including expedited report submissions, internal audits, regulatory inspections and training. You’ll learn:
Boris Videlov, Director, Compliance & Quality Management, Forest Research Institute, subsidiary of Forest Laboratories |
12:30 p.m. – 1:30 p.m. |
Lunch |
1:30 p.m. – 2:15 p.m. |
Form 483 and Warning Letter Response Panel Moderator: Peter Calcott, Ph.D., Co-Chair, President, Calcott Consulting
Rome wasn’t built in a day ... but the FDA expects your response in 15! Commissioner Hamburg has put the industry on notice: Respond appropriately to 483s in 15 business days or face warning letters. But here’s the silver lining: Despite a warning letter, you still can earn a “closeout letter” that deems the enforcement action effectively ended. Panelists will discuss the new 15-day response window ... what the FDA expects of your initial and follow-up responses ... and how to assure you get that much-sought-after “closeout letter.” |
2:15 p.m. – 3:00 p.m. |
Sanofi Pasteur Case Study: CAPA Investigations of Non-Conforming Product From Third-Party Suppliers Sanofi Pasteur investigated a labeling non-conformance from a third-party supplier, discovered the root cause and instituted an immediate correction, corrective action, preventive action and effectiveness verification. Here’s how they did it! You’ll learn:
Edit Szocs, CAPA Manager, Sanofi Pasteur |
3:00 p.m. – 3:15 p.m. |
Refreshment Break |
3:15 p.m. – 4:00 p.m. |
Warning Letter Review: Collecting All the CAPA Puzzle Pieces – Integrating GLP and GCP Into Your GMP CAPAs The FDA has made it clear that sponsors are responsible for managing risk at each stage of the drug or biologic life cycle. Even though a majority of CAPA-related warning letters reference GMP offenses, increasingly warning letters cite problems with GLP and GCP. This review will describe how a robust CAPA program based on GLP and GCP audits can add to your firm’s defenses. You’ll explore:
Janice Wilson, Ph.D., Vice President,
Quality Assurance & Compliance,
Elan Pharmaceuticals |
4:00 p.m. – 5:00 p.m. |
Free for All! A “Put Away the PowerPoint” Panel Moderated by Jim Darnell, Co-Chair, President, CompliaPharm, LLC
No PowerPoint presentations in this interactive panel — just a frank discussion and exchange of ideas! It’s a golden opportunity to ask panelists and peers for solutions to your toughest problems and most pressing concerns ... highlight valuable lessons learned ... and share what you intend to bring home from the Congress. |
5:00 p.m. – 7:00 p.m. | Adjournment and Networking Reception |
DAY TWO Thursday, Dec. 3 | |
8:30 a.m. – 9:00 a.m. |
Continental Breakfast |
9:00 a.m. – 9:15 a.m. |
Welcome and
Introduction |
9:15 a.m. – 10:15 a.m. |
FDA’s Risk-based Approach — Integrating Risk Analysis and CAPA The FDA increasingly is reviewing drug and biologic systems from a risk-based perspective as it enforces adherence to GMPs and inspections. In this session you will discover how a top CDER official views the intersection of risk assessment analysis and CAPA.
Richard Friedman, Director, Division of Manufacturing & Product Quality, Office
of Compliance, CDER, FDA (invited) |
10:15 a.m. – 10:30 a.m. |
Refreshment Break |
10:30 a.m. – 11:15 a.m. |
Wyeth Pharmaceuticals Case Study: Managing the Inevitable With CAPA Trend Analysis With CAPA inputs coming from every direction, continuous improvement depends on the ability to identify true root causes or most probable causes of events. Learn how Wyeth crafted systems to monitor CAPA trends, assess CAPA system effectiveness and apply appropriate remediation. You’ll learn:
Nancy Fulginiti, Global Quality & Compliance, Pharmaceutical Network Quality, Wyeth Pharmaceuticals |
11:15 a.m. – 12:15 p.m. |
CAPA Lessons Learned: A Panel Discussion
Review highlights ... get answers to nagging questions ... pick the brains of panel experts and fellow attendees. |
12:15 p.m. | Adjourn |