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How to Prepare For and Host a FDA Inspection and Respond to 483’s
Edwin Waldbusser
LIVE : March 19 , 2026 01:00 PM EST
Life Sciences > Medical Devices
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development ...
Showing 471-480 of 705 items.
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Successful FDA Meeting Preparation and Conduct
Peggy J Berry
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also pro...
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Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production
Carl Patterson, MS, SSGB, SSBB
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, Ca...

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Are You Ready for New FDA FSMA (Food Safety Modernization Act) Audit?
Gina M. Reo
Recorded Duration : 60 Minutes
Life Sciences > Food Safety And Dietary Supplements

President, QAS, (Quality Assurance Strategies, LLC), private consultation for the Food and Beverage Industry specializing in Global Food Safety...

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Human Factors Engineering in New Product Development
Tom Kramer
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Tom Kramer, president and CEO of Kablooe Design, has been a product innovator for over 26

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Cleanroom Practices and General Chapter USP <797>
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. ...

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Cleanroom Practices and General Chapter USP <797>
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. ...

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Medical Device Classification Process in the United States and the EU
Charles H. Paul
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant...
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How to Prepare HIPAA Compliant Policies and Procedures
Jim Wener
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

Jim Wener has over 40 years of experience in assisting health care organizations - both providers and payers - in identifying their automation ...

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Demonstrated Techniques to a Successful 510k Submission
Mercedes Massana
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, bio...
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HIPAA vs SAMHSA (42 CFR Part 2)
Brian Tuttle
Recorded Duration : 90 Minutes
Life Sciences > Healthcare
Brian Tuttle CPHIT, CHP, CBRA, Net+, A+, CCNA, MCP is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor ...
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