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CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
July 23, 2014 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online training will benefit professionals in the Pharmaceutical, Biotechnology and Medical Device industries and will be especially valuable to those holding positions such as:
• CRP, CRC, CRA (Clinical research professionals,
coordinators, and associates)
• Project Managers, Directors
• Quality Assurance
• Regulatory Affairs
• Auditors/Monitors
In departments such as:
• Regulatory
• Operations
• QA/QC
• Clinical Description
This course will be available On Demand: July 24, 2014
This 90-minute accredited online training developed and presented by a former FDA medical officer will provide an overview on how FDA sees and assesses your study site for approval. In addition, this former FDA “insider” will guide participants through the current thinking on Risk Based approach to clinical studies for marketing approval for drug and devices. Case studies will be used to demonstrate that it is possible to prepare for FDA visits. Knowing how to prepare will help ensure success during the audit and how to properly address any FDA issues or concerns. Bring your questions as together we de-mystify the process of FDA inspections/audits and help you learn how to “see and think” like a regulator and become a futurist thinker.
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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Dr. Jerri Perkins, founder and President, Barden-Perkins Consulting
Dr. Jerri Perkins, has been assisting industry professional in preparing for FDA inspections for over 25 years. She has assisted companies in preparing IND, NDA, ANDA, IDE, PMA and 510(k) submissions. Previously, Dr. Perkins was a Medical Officer for FDA and was an Acting Division Director, involved in policy decisions in the Office of the Commissioner, and a Reviewing Medical Officer for drugs. She made recommendations to the FDA Commissioner on whether or not unsafe products should be recalled from the market. She also made recommendations on whether or not drugs were safe and effective for the U.S. market.
Dr. Perkins did her post-doctoral research at the National Institutes of Health (NIH) in Bethesda, MD, and received her MD degree from the Medical College of Virginia. She received her BS from Mary Washington College of the University of Virginia.
She has published basic research articles while at the NIH and articles regarding FDA issues. She has given numerous presentations in the U.S.A. and Europe and was an invited speaker in China and most recently in India.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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