This webinar was previously recorded and can be found on our YouTube Channel's Playlist.
FDA is undergoing one of its greatest re-alignments and inspection method updates
in the past 30 years. The new enforcement and organizational alignments go officially
into place on May 15, 2017. The new inspection methods are being rolled out this year.
Simply put, what this means for you is two things:
- The old ways of preparing for an inspection are now officially outdated and outmoded. New investigators arrive with iPads and want to see electronic records.
- FDA's risk-based inspection priorities means less inspections - but more rigor and more likelihood of enforcement. In other words, when FDA shows up, it's likely because they've already detected a problem at your site or with your products.
This 1-hour webinar will address:
- What FDA new inspection methodologies look like for medical device and pharma firms;
- The significance of this to your life sciences company; and
- What you need to start doing to prepare.
John Avellanet is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging, friendly style.
Mr. Avellanet serves as a lead expert in the ISPE’s Data Integrity working group and was the industry expert reviewer for the international standard, Evidential Weight and Legal Admissibility of Electronic Information (BSI 10008).
He has trained FDA and Health Canada officials on data integrity, and routinely offers public workshops on data integrity best practices as well as more private, customized data integrity training to clients around the world.
In 2014, Mr. Avellanet co-authored the book, Pharmaceutical Regulatory Inspections along with several current and former regulatory agency officers, and was the lead author of several certification courses for the US Regulatory Affairs Professional Society (RAPS).
In 2011, Mr. Avellanet was asked by the US Department of Justice and the US Office of Inspector General, Health & Human Services, to oversee the multi-million-dollar Dr. Comfort Corporate Integrity Agreement (CIA) through 2016.
His industry classic book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine, was originally featured at BIO 2011. In both 2009 and 2011, Mr. Avellanet won the “Best of Business” award from the US Small Business Commerce Association. His blog, ComplianceZen.com, has been repeatedly named one of the “Top 50 Blogs” worldwide on FDA compliance issues.
Over the past 10 years, he has been interviewed on public radio programs, in numerous industry magazines and multiple international news outlets. He has written more than 100 different articles on cost-effective FDA compliance, many of which have been translated and syndicated around the world. He speaks frequently for industry conferences and private corporate workshops.
Prior to founding his lean compliance consulting firm, Cerulean Associates LLC, Mr. Avellanet was a former Fortune 50 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, DEA, BIS and FDA compliance. During his career, he has had to defend decisions to investigators, auditors, and litigators alike. He now brings his hard-won, real-world expertise and practical advice to corporate clients worldwide.
A former FDA and US Department of Justice prosecutor has said of Mr. Avellanet, “He is the best in the business. Period.”