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FDA Compliance

‘CAPA Is King’ Virtual Conference

Dec. 13, 2011, from 10 a.m.–4 p.m. EST

Published: Tuesday, November 15, 2011 - 12:50

(FDANews: Falls Church, VA) -- FDAnews has announced details of its upcoming CAPA is King Virtual Conference: Tools, Tips, and Techniques for Assuring Compliance, to be held online Dec., 13, 2011, 10 a.m.–4 p.m. EST.

These days more than two-thirds of all Food and Drug Administration (FDA) warning letters cite corrective and preventive action (CAPA) deficiencies in how a firm conducts related investigations. The FDA doesn’t just look just for compliance, but also for risk. Inspectors want to see that companies are proactively identifying and fixing risks as well. Also, agency investigators now scrutinize CAPAs to trace the dotted lines that connect drug and device sponsors to problems beyond CAPA.

For example, it’s no longer enough for organizations to catch a problem and halt distribution. Now they must track down units that are already in the field—and manage them properly, too.

Developing a successful CAPA program has never been more important. Yet history proves that drug and device firms have a steep learning curve. However, drug- and device-makers that can demonstrate their CAPA programs are effective and adequate are in line for the FDA’s blessing.

Clear your calendar for Tues., Dec. 13, and plan to spend the day near a computer screen. It’s the CAPA event of the year, a virtual regulatory conference sponsored by FDAnews where Washington comes to you.

View the complete virtual conference agenda here.

Seth Mailhot, conference chairperson, is special counsel in the Washington D.C. office of Sheppard Mullin, and a member of the firm’s Food and Drug Law Group Life Sciences Group. Mailhot’s 14 years working in the FDA provides a unique perspective in his counseling of clients on a broad range of matters involving the FDA.

While working at the FDA, Mailhot served in a variety of capacities and oversaw activities of pharmaceutical, biologic, medical device, food, and cosmetic- and dietary-supplement companies. His FDA regulatory experience includes enforcement and recall matters; preparation and prosecution of FDA premarket submissions such as 510(k)s, PMAs, NDAs, ANDAs, INDs, IDEs, pre-INDs and pre-IDEs; product promotion and labeling issues; pharmaceutical exclusivity matters; and compliance with quality, regulatory, and manufacturing requirements. While at the FDA, he was a Level II-certified medical device investigator and conducted foreign and domestic inspections.

Other speakers include:
• Elaine Messa, director of Medical Device Quality Systems and Compliance Practice, Becker & Associates, former director of the FDA’s Los Angeles District
• Elizabeth Luczak, global head of SRM Quality Safety Alliances, Pfizer
• Barbara Immel, president of Immel Resources LLC, editor of the Immel Report

Looking for program specifics? Check these out:
• Three techniques that elicit feedback to ensure CAPA programs are functioning properly
• What should—and should not—be in your comprehensive response to CAPA observations
• Five management tips and tools to improve performance, close out CAPAs in a timely manner, and avoid observations and violations related to your CAPA systems
• Developing CAPAs that integrate GLP and GCP best practices: what the FDA requires sponsors to include
• Prioritizing activities and corrective actions to ensure long-term success
• Techniques for improving your chances of getting a close-out letter

No planes, trains, or automobiles

No doubt you’d probably be willing to board a Washington-bound plane, check into an unfamiliar hotel, and spend two or three days away from your desk to attend a conference. Good thing you don’t need to. Some of the benefits of virtual conferencing include:
• Stress-free. No airport security hassles or waking at 4 a.m. to catch an early flight. You never even leave your building—not even your own desk.
• Interactive. Constant opportunities to ask questions and get involved. Send in queries via e-mail; you’ll have answers before you log off.
• Up to the minute. Every speaker operates in the real world, in real time. If something important happens on virtual-conference morning, you’ll hear about it before the sessions end.
• Great value. There’s no limit on number of attendees per site. One low registration fee covers them all.

Here’s how it works

Twenty-four hours prior to the conference on Tues., Dec. 13, attendees will receive all presentations. Then just log on to the conference website and dial a toll-free number, both provided in your registration confirmation. That’s all there is to it.

The tuition is $1,297 per site and includes virtual conference registration, audio CDs, and transcripts. Contact customer service to make any substitutions.

Register online, or call (888) 838–5578 or (703) 538–760.


About The Author

FDAnews’s picture


FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the U.S. Food and Drug Administration (FDA). Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books, special reports, and conferences to stay in compliance with international standards and FDA’s complex and ever-changing regulations to get their products to market faster and boost profits.