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Challenges to be Encountered while conducting FDA Remote Inspections in the Post COVID Era
August 19, 2020 @ 6:00 pm - 7:30 pm$10 – $25
Challenges to be Encountered while conducting FDA Remote Inspections
in the Post COVID Era
1.5 Hours Towards Your RAC Recertification
AUG 19 2020
6:00 pm – 7:30 pm
Program Manager: Eri Hirumi, Program Chairperson for OCRA
Speakers: Marlene Garcia-Swider, PhD, CQM, CSSBB, PMP
We are all under the new challenging COVID Era. Standard processes have been uprooted and we all face the challenge of performing many functions remotely. One such process is preparing for the FDA Inspections. These inspections are stressful enough, but the added complexity of managing the COVID requirements can be overwhelming.
Come and hear how the FDA is handling this and what you can expect. Forewarned is being Forearmed.
Through this presentation you will gain knowledge on the different types of remote audits available, the advantages and disadvantages these present and how to best prepare according to current regulations for your remote audits. Through this presentation you will learn about tools Dr. Swider has used as past FDA auditor and as current consultant to Pharmaceutical companies that will facilitate your audits. The presentation will include her own perspectives, real stories & experiences while also address questions you may have on how to survive remote audits in a Post COVID-19 era.
- OCRA Members: $25
- Non-Members: $100, includes 1-year OCRA membership
- Government and Student Members: $10, with student/government ID
- Non-Member Government and Student Rate: $45, includes 1-year OCRA membership
Hi! My name is Dr. Marlene Garcia Swider and I am happy to share with you my perspective as how FDA will be addressing future audits. My information is based on 32 years of experience working for FDA as an Investigator, Reviewer and Scientist for Biotechnology drugs and recent public information published by the FDA. I also served as Quality Manager and Public Affairs Specialist for FDA working with Congress. Currently retired from FDA, I started my own consulting firm – Biotech Online to train as a consultant and prepare customized Regulatory Affairs and Quality courses for Industry. I also enjoy spending time teaching management, leadership, clinical trials, and regulatory affairs at California State University and Azusa Pacific University. Other passions of mine include community service and coordination of events. Some of my certifications include Project Management, Six Sigma Black Belt and Continuous Improvement in Social Responsibility.
OCRA Registration Instructions
It is important that you register with the name and email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance.
Certificates of attendance will be emailed within a day of the event.
Registration deadline is August 18. Same day registrations not available.
OCRA’s non-profit Federal Tax ID# 33-0630455
For a refund, please email your cancellation request to OCRA Program Chair (email@example.com) by August 18, 2020.
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