In this webinar, top regulatory consultant, John Avellanet, will present a look at potential changes facing FDA-regulated industry in the coming year. This is a critical moment at FDA with both the recent confirmation of a new FDA Commissioner and the looming election likely to impact the Agency’s regulatory and enforcement strategies.
This webinar will address:
- A look at the new FDA Commissioner, Dr. Stephen Hahn, a former radiation oncologist at MD Anderson Cancer Center;
- Important regulatory changes and standards introduced in the past year; and
- Insights into likely enforcement priorities for FDA in the year ahead.
John Avellanet is an internationally renowned speaker, expert and authority on data integrity and lean compliance practices for FDA cGMP, cGCP, QSR, 21 CFR Part 11, ICH and IMDRF.
He has trained FDA investigators and district officers, Health Canada officials, spent over 15 years being directly accountable for data integrity and regulatory compliance, and during his career, passed multiple regulatory inspections. He was personally trained by the authors of 21 CFR 11 to conduct FDA inspections himself. Mr. Avellanet has been called “the best in the business” by former FDA and Department of Justice officials.
Trusted by officials at FDA, NIH, DOJ, and the HHS OIG, as well as by corporate clients around the world, Mr. Avellanet provides practical, business-savvy solutions to strengthen compliance while lowering costs and reducing risk. He speaks frequently at industry conferences and private organizations around the world.