FALLS CHURCH, Va.,Prepare Your Drug/Biologics Facility for the New FDA Inspection Model:
Will It Be Remote, In-Person or Hybrid?
An FDAnews Webinar
Tuesday, March 22, 2022, 1:30 p.m.–3:00 p.m. EDT
The uncertainty of the ongoing pandemic brought another kind of ambiguity: will pharmaceutical or biologics facility inspections be remote, in-person or hybrid? If manufacturers are unclear on how best to ready their facility for inspection, this webinar has the answers.
The three presenters, two of whom are former directors within the FDA’s Center for Drug Evaluation and Research (CDER), will share what manufacturers must understand about the FDA’s new remote tools and how to prepare for remote record requests and remote interactive evaluations.
And the drugmakers that have fallen behind on traditional inspection preparedness during the pandemic will benefit from the discussion of the risk areas to focus on as they conduct inspection readiness activities.
Cynthia Schnedar, principal of regulatory compliance for Greenleaf Health; Steven J. Lynn, executive vice president of pharmaceuticals for Regulatory Compliance Associates; and Bob Rhoades, managing partner at Validant, will explain how to stay compliant by:
Being ready for an FDA inspection of a drug or biologics facility, whether remote or in-person Understanding the remote tools used by the FDA in a virtual inspection so manufacturers can adequately prepare Deploying specific inspection-readiness strategies no matter how the FDA decides to carry out an facility inspection Closing gaps in traditional inspection-readiness activities due to the pandemic Evaluating risk areas as manufacturers conduct inspection-readiness activities
Get ready for any inspection contingency and maintain compliance with the taken away from this webinar.
Webinar Details:
Prepare Your Drug/Biologics Facility for the New FDA Inspection Model:
Will It Be Remote, In-Person or Hybrid?
An FDAnews Webinar
Tuesday, March 22, 2022, 1:30 p.m.–3:00 p.m. EDT
https://wcg.swoogo.com/prepare-your-drug-biologics-facility
Tuition:
$297 per site
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.
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