First Annual CAPA Congress Agenda

DAY ONE Wednesday, Dec. 2

8:30 a.m. – 9:30 a.m.

Registration and Continental Breakfast

9:30 a.m. – 9:45 a.m.

Welcome and Introduction
by Peter Calcott, Ph.D., Co-Chair, President, Calcott Consulting

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:

  • The PIT Team: What it is, who should lead it, who should belong
  • Challenges and solutions: Helping the PIT Team work effectively for best CAPA results
  • Executive support: How to gain it for the PIT Team
  • Regulation: What is the PIT Team’s regulatory status?
  • Audits: Should the PIT Team be shielded from them?

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:

  • How to improve processes, partner relations, consistency, quality and compliance
  • 3 challenges to tracking drug safety: system selection, development and maintenance
  • How to create a centralized location for incident tracking
  • Standardized processes for tracking, analyzing and resolving incidents

Boris Videlov, Director, Compliance & Quality Management, Forest Research Institute, subsidiary of Forest Laboratories

12:30 p.m. – 1:30 p.m.


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:

  • Techniques to identify the root cause of a nonconformance, emphasizing timeliness and criticality
  • Determining the extent of a nonconformance, minimizing quality risk and isolating an incident
  • How to include the supplier(s) in the investigation and CAPA process (where applicable)
  • How maintaining approved suppliers with GMP-compliant quality systems in place can alleviate pressure during an inspection

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:

  • How frequently ignored GLP and GCP best practices can improve the stability of your CAPAs
  • Developing CAPAs that integrate GLP and GCP best practices — what the FDA requires sponsors to include
  • 3 techniques that elicit feedback to assure CAPA programs are functioning properly

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
by Jim Darnell, Co-Chair, President, CompliaPharm, LLC

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:

  • Why root cause and CAPA trending are important and how trending CAPA can help improve compliance
  • How to create a CAPA trending program and what systems must be in place
  • Ensuring your CAPA trending program remains effective

Nancy Fulginiti, Global Quality & Compliance, Pharmaceutical Network Quality, Wyeth Pharmaceuticals

11:15 a.m. – 12:15 p.m.

CAPA Lessons Learned: A Panel Discussion
Moderated by Jim Darnell, Co-Chair, President, CompliaPharm, LLC

Review highlights ... get answers to nagging questions ... pick the brains of panel experts and fellow attendees.

12:15 p.m. Adjourn