Each link will take you to a more detailed page on the Cerulean website where you can download the seminar’s agenda, see all the various learning points covered, and purchase the recorded seminar.
How to Improve Data Quality & Record Integrity in Your NDA, BLA, or 510(k)
Based on a presentation and joint workshop given with FDA’s Helen Winkle and PharmaQbD, this seminar lays out what the FDA is looking for when it comes to record integrity and data quality problems in regulatory submissions and supporting materials. Learn more….
Best Practices for Your Quality System Management Review (QSMR)
Draws upon discussions with FDA, GHTF, and EMA officials, internal agency documents, and analyses of various FDA enforcement actions, this seminar shows you precisely how to avoid wasting time and how to get the most powerful results from your quality system management reviews to improve compliance effectiveness, reduce risks, and lower costs. Learn more….
Bulletproof Yourself Against FDA Enforcement
One of Mr. Avellanet’s most popular seminars, this recording will show you a sensible, constructive way to prepare your FDA quality system, regulatory affairs processes, and overall compliance program to handle inspections and encourage a positive, rapid “close-out” letter. Learn more….
FDA Quality System Records Requirements and Retention for Pharmaceutical, Biotech, and Devices – GLPs, GCPs, GMPs, QSRs
Learn the requirements and how to meet them in a practical, enforceable system from an executive who had to build a records management department from the ground up to be compliant with ISO and the FDA, and who had to successfully defend that department, its policies and SOPs, and his own decisions during litigation and audits. Learn more….
To talk with the author about conducting an onsite or over-the-web seminar for your organization or event, see scheduling a speaking engagement.
John Avellanet is an excellent speaker – one of the best I have ever heard. His message is direct, clear, timely, and relevant. His visuals enhance the message. He also includes many of his personal experiences that further support the discussion. Any organization or conference director would do well to make sure he’s prominent on the program.
- Paul Pluta, Institute of Validation Technology
