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 Attendees will learn:
Elizabeth Luczak, Global Head, SRM Quality Safety Alliances, Pfizer |
11:15 a.m. – 11:30 a.m. |
Break |
11:30 a.m. – 12:30 p.m. |
Replying to CAPA Related 483s and Warning Letters — How to Achieve the Elusive Close-out Letter Attendees will learn:
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. |
Lunch |
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 Attendees will learn:
Janice Wilson, Vice President Quality Operations, Elan Pharma |
2:30 p.m. – 2:45 p.m. |
Break |
2:45 p.m. – 3:45 p.m. |
Examining Poor Management Practices that Lead to CAPA 483s and Warning Letters Attendees will learn:
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?
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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?
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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.