Prepare Your Drug/Biologics Facility for the New FDA Inspection Model: Will It Be Remote, In-Person or Hybrid? – Webinar Recording/Transcript
Product Details
If you don’t know what to expect, you can’t be ready — especially when it comes to an FDA inspection of your facility. These days, you have to be ready for any kind of inspection: remote, in-person or hybrid.
Don’t let an FDA inspection of your facility throw you into chaos: you need this presentation.
The three presenters — two of whom are former directors within the FDA’s Center for Drug Evaluation and Research (CDER) — will share what you must understand about the FDA’s new remote tools and how to prepare for remote record requests and remote interactive evaluations.
And if you’re one of the many drugmakers that has fallen behind on traditional inspection preparedness during the pandemic, you’ll benefit from their discussion of the risk areas to focus on as you 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.
Presentation Takeaways:
- Be ready for an FDA inspection of your facility, whether remote or in-person
- Understand the remote tools used by the FDA in a virtual inspection so you can adequately prepare
- Deploy specific inspection-readiness strategies no matter how the FDA decides to carry out an inspection of your facility
- Close gaps in your traditional inspection-readiness activities due to the pandemic
- Evaluate risk areas as you conduct inspection-readiness activities
Get ready for any inspection contingency — and maintain compliance — with the intel you’ll take away from this webinar.
Meet Your Presenters
Cynthia Schnedar, principal of regulatory compliance at Greenleaf Health, provides strategic advice to clients in the life sciences industry. She was formerly director of the CDER Office of Compliance. Schnedar previously served at the Department of Justice (DOJ) as acting inspector general and in other leadership positions focused on compliance and enforcement issues. She also served as a prosecutor and a civil trial attorney for DOJ.
Steven J. Lynn, executive vice president of pharmaceuticals for Regulatory Compliance Associates (RCA), has more than 20 years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. Joining RCA in September 2020, Mr. Lynn serves as executive vice president of pharmaceuticals. Prior to joining RCA, he served in executive leadership roles with global accountability in the private sector as well as at the FDA. While at the agency, he was the director of CDER’s Office of Manufacturing and Product Quality. In this role, he was responsible for the global oversight of all drugs manufactured and/or imported into the U.S. In addition, in his last year at the FDA, he also served as the operations transition lead for CDER’s new Office of Pharmaceutical Quality.
Bob Rhoades, managing partner at Validant, focuses on helping companies navigate the regulatory landscape while keeping pace with their corporate direction and strategy. A skilled practitioner of both quality system regulation and pharmaceutical GMPs for nearly four decades, Mr. Rhoades has designed and implemented compliance improvement initiatives for major manufacturers around the world. Before joining Validant, he led the quality and compliance consulting practice for Quintiles and served in consulting leadership roles at Becker & Associates and Impact Management Services. He also served in key executive positions at Solvay Pharmaceuticals, Bausch & Lomb and Baxter Healthcare.
Who Will Benefit
- Quality specialists
- Regulatory specialists
- Compliance specialists