10:00 a.m. – 10:15 a.m.

Introduction to the Virtual Conference

Chairperson, Seth Mailhot, Counsel, Nixon Peabody, former Compliance Officer and Medical Device Investigator, New England District Office, FDA

10:15 a.m. – 11:15 a.m.

Pfizer Case Study — Demonstrating CAPA Effectiveness
This session will provide an analysis of the components within a CAPA system for promoting sustainable and effective corrective and preventive actions. Attendees will learn one company’s approach to strengthening its CAPA processes within a complex and global organization. This interactive presentation will describe tools and approaches for monitoring CAPA effectiveness and how to demonstrate the sustained impact of these actions over time.

Attendees will learn:

  • How to engage stakeholders and instill accountability
  • Remediation vs. prevention – how they differ and why they’re both important
  • Best practices for monitoring issues, actions and progresses
  • Designing and measuring CAPA effectiveness
  • Tips for sustaining CAPA impact for the long-term

Elizabeth Luczak, Global Head, SRM Quality Safety Alliances, Pfizer

11:15 a.m. – 11:30 a.m.


11:30 a.m. – 12:30 p.m.

Replying to CAPA Related 483s and Warning Letters — How to Achieve the Elusive Close-out Letter
Under new enforcement initiatives announced by Commissioner Hamburg, companies have 15 working days to submit responses to FDA 483s or warning letters, detailing substantial systematic changes. Successful responses require significant planning and prioritization. Learn response tips and techniques specific to the CAPA subsystem to best position your company for the highly sought FDA “close-out letter”.

Attendees will learn:

  • Necessary elements of a comprehensive response to CAPA observations
  • How to prioritize activities and corrective actions for success
  • Maximizing potential for receipt of a “close-out letter”

Elaine Messa, Director, Medical Device Quality Systems and Compliance Practice, Becker & Associates, former Director of the FDA’s Los Angeles District

12:30 p.m. – 1:30 p.m.


1:30 p.m. – 2:30 p.m.

Warning Letter Review: Collecting All the CAPA Puzzle Pieces — Integrating GLP and GCP Into Your GMP CAPAs
The FDA has made is 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 presentation will describe how a robust CAPA program based on GLP and GCP audits can add to your firm's defenses.

Attendees will learn:

  • 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, Vice President Quality Operations, Elan Pharma

2:30 p.m. – 2:45 p.m.


2:45 p.m. – 3:45 p.m.

Examining Poor Management Practices that Lead to CAPA 483s and Warning Letters
The key to a successful CAPA system is effective management. The most common CAPA violations cited in warning letters stem from poor management practices. This presentation will discuss some commonly encountered CAPA violations found in device warning letters, and provide tips on how to strengthen managerial oversight to avoid such problems. The presentation will also discuss some other common CAPA management problems that can impact the efficiency of the system and the effectiveness of the actions taken.

Attendees will learn:

  • The most common CAPA violations cited in device warning letters
  • 5 management tips and tools to improve performance, close out CAPAs on a timely basis, and avoid observations and violations with your CAPA system
  • Trend analysis of the frequency of CAPA observations and violations identified by the FDA
  • How seemingly unrelated events can create CAPA pitfalls that impact a system’s efficiency and quality

Chairperson, Seth Mailhot, Counsel, Nixon Peabody, former Compliance Officer and Medical Device Investigator, New England District Office, FDA

3:45 p.m. – 4:00 p.m.

Closing Comments and Adjournment

Chairperson, Seth Mailhot, Counsel, Nixon Peabody, former Compliance Officer and Medical Device Investigator, New England District Office, FDA

How does this virtual conference work?

The Cleaning Validation for Drugs and Biologics Strategies for Managing Your Biggest Compliance Challenge Virtual Conference takes all the best elements of the best live conference you’ve attended and avoids all the negatives. It delivers valuable clinical trial development intelligence using the internet for visual components and your speakerphone for the accompanying audio.

All you do is go to the specified website on the day of the event and dial the specified toll-free telephone number, both provided in your registration confirmation. That’s all there is to attending.

Then, relax at your desk or in your conference room, enjoying summit sessions featuring PowerPoint slide presentations, helpful handouts and Q&A opportunities where specific attendee questions will find direct answers from leading supply chain professionals.

What are the top benefits of a virtual conference?

Highly effective communication: This event uses internet and audioconferencing to create a seamless interface and deliver vital compliance and management advice using technology found in every workplace.

Great value: Select as many of your colleagues to attend as you wish and educate everyone for one low price, with no travel, lodging or per diem expenses.

Stress-free: No hotel or airport nightmares because you never have to leave your building. You’ll feel like you’re off-site at a top-flight conference, until you realize how easy it is to get things done during breaks.

Efficient: You can assign your staff to different sessions.  Staffers can go to the sessions that most pertain to their responsibilities.

Content-rich: This virtual conference addresses your most challenging, complex and frustrating supplier quality problems.

Interactive: No one-way street, you’ll have plenty of opportunities to ask questions and get involved.

Up to the minute: This program will be up to the minute with the latest changes initiated by the FDA and international regulatory bodies incorporated into the event.

Comprehensive: You’ll hear from six industry experts all in the course of one day.