Pharmaceutical Postmarket Surveillance - Latest Developments in the Era of COVID-19

Michael C Redmond

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Are you compliant with the postmarket surveillance guidance the FDA released during the pandemic? And the current FDA postmarket adverse event reporting regulations?

If the pandemic is making your postmarket surveillance even more difficult, you’re not alone.

During this webinar, two former FDAers explain how to comply during the pandemic and beyond.

Our speaker, will ensure you understand how the agency conducts its postmarket safety surveillance and what you must do to ensure postmarket adverse reporting inspection readiness.

Webinar Takeaways:

  • What the FDA Adverse Event Reporting System (FAERS) is, how the FDA evaluates the information in the FAERS database and what regulatory action that FDA may take if it detects a safety signal from its data review
  • Nuances of the FDA Program Guide CHAPTER 53 — Postmarketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products Program: 7353.001, including how this program guide is a critical tool that sponsors should be using to ensure they are in compliance and prepared for an FDA inspection on postmarket adverse event reporting
  • How the FDA uses its MedWatch program to provide information on mandatory reporting by manufacturers
  • What type of reports a manufacturer must submit to the FDA when deviation from current good manufacturing practice regulations occur
  • What data elements are required for valid adverse event submissions
  • How the FDA will evaluate adverse event reporting during a postmarket inspection

Make sure your postmarket safety surveillance is compliant during the pandemic and beyond by attending this webinar. Join us by registering today.

Who Will Benefit

  • Auditors
  • QA/QC personnel
  • R&D management
  • Compliance officers
  • Executive management
  • Laboratory management
  • Risk management specialists
  • Regulatory/legislative professionals
  • Manufacturing directors and supervisors
  • Validation specialists, scientists
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Michael C Redmond, CEO and Lead Consultant, Redmond Worldwide

Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.

Michael's MBA in Risk Management included courses in Information Security and Risk Management for Medical Devices and Healthcare. Michael is certified as a Senior Lead Manager in Information Security for Healthcare ISO 27999.As a practitioner, she has been implementing ISO 27999 and ISO 14971 for over 10 years for clients. 

Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.

Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.

Get in touch

(315) 632-0735,
(315) 750-4379