CAPA Is King Tools, Tips and Techniques for Assuring Compliance


Master CAPA compliance in a day?

Learn latest FDA thinking and best practices from industry leaders and deep thinkers?

Today, more than two-thirds of all FDA warning letters cite CAPA deficiencies or deficiencies in how a firm conducts related investigations.

To make matters even worse, the FDA doesn’t just look 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 uncover the dotted lines that connect drug and device sponsors to problems beyond CAPA. 

Example: It’s no longer enough for you to catch a problem and halt distribution. Now you’ve got to 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.

As bad as it seems, there is a silver lining.  Drug- and devicemakers that demonstrate that their CAPA programs are effective and adequate, are in line for the FDA’s blessing.

So … suppose you could invite the top CAPA experts in the land into your conference room — industry and legal pros with decades of FDA experience under their belts, now working with regulated manufacturers like you — and discover how to institute CAPA practices that all but guarantee a close-out letter.

Suppose they spent a full day of give and take with you and your staff, briefing you on the latest FDA thinking plus proven techniques that have worked for companies like yours.

It’s not fantasy, but reality.

It’s the CAPA audio CD/transcript of the year, a virtual regulatory conference sponsored by FDAnews where Washington comes to you.

Straight from the Shoulder

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, as well as the firm's Life Sciences Group.  Mr. 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, Mr. Mailhot served in a variety of capacities and oversaw activities of pharmaceutical, biologic, medical device, food, cosmetic-, and dietary supplement companies. Mr. Mailhot’s 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. 

Mr. Mailhot’s understanding of manufacturing regulations and current good manufacturing practices spans all industries, with a focus on regulatory issues involving foreign manufacturing. 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, Medical Device Quality Systems and Compliance Practice, Becker & Associates, former Director of the FDA’s Los Angeles District

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

Barbara Immel, President, Immel Resources LLC, Editor of the Immel Report

Looking for program specifics? Check these out:

  • 3 techniques that elicit feedback to assure CAPA programs are functioning properly
  • What should — and should not — be in your comprehensive response to CAPA observations
  • 5 management tips and tools to improve performance, close out CAPAs on a timely basis, 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 assure long-term success
  • Techniques for maximizing your chances of getting a close-out letter
  • And much, much more

Who Will Benefit

  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Engineering and design control teams
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • R&D staff
  • Regulatory affairs professionals
  • Risk management specialists
  • Training personnel

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600