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Navigating FDA's Regulation on the Use of Social Media

Carolyn Troiano

Recorded Duration : 90 Minutes

Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated indust...

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510(k) Third Party Review Program – Latest Guidance, Changes, Challenges, and Opportunities

John E. Lincoln

Recorded Duration : 90 Minutes

Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated ind...

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3-hr Virtual Seminar: Understanding CAPA for Medical Devices to Ensure Compliance

Susanne Manz

Recorded Duration : 180 Minutes

Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background ...

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Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration

Jose Mora

Recorded Duration : 90 Minutes

Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences ind...

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Packaging and Labeling in the Pharmaceutical Supply Chain

Michael Esposito

Recorded Duration : 75 Minutes

Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Michael Esposito has over 30 years experience in the pharmaceutical industry and 18 years experience in GMP training and document management. H...

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World Class Program for Smartly Managing FSMA (Food Safety Modernization Act) Compliance, Post COVID

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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Remote Auditing for GMP Compliance During COVID-19: Challenges and Opportunities

Gina M. Reo

Recorded Duration : 75 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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Extractables & Leachables in Drug Development

Dr. Stefano Persiani

Recorded Duration : 60 Minutes

Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmac...

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21 CFR Part 11 - Electronic Record and Signature Validation

Edwin Waldbusser

Recorded Duration : 60 Minutes

Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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 ...

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Software Validation Utilizing Principles of Lean Documents and Lean Configuration

Jose Mora

Recorded Duration : 90 Minutes

Life Sciences > Medical Devices

Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences ind...

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Recorded

Essentials of Validation – IQ, OQ, PQ

LIVE : April 08 , 2025 01:00 PM EST

21 CFR Part 820 - Quality System Regulation - Principles of Lean Documents and Lean Configuration

Jose Mora

LIVE : April 09 , 2025 01:00 PM EST

Navigating FDA's Regulation on the Use of Social Media

Carolyn Troiano

Recorded Duration : 90 Minutes

510(k) Third Party Review Program – Latest Guidance, Changes, Challenges, and Opportunities

John E. Lincoln

Recorded Duration : 90 Minutes

3-hr Virtual Seminar: Understanding CAPA for Medical Devices to Ensure Compliance

Susanne Manz

Recorded Duration : 180 Minutes

Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration

Jose Mora

Recorded Duration : 90 Minutes

Packaging and Labeling in the Pharmaceutical Supply Chain

Michael Esposito

Recorded Duration : 75 Minutes

World Class Program for Smartly Managing FSMA (Food Safety Modernization Act) Compliance, Post COVID

Gina M. Reo

Recorded Duration : 60 Minutes

Remote Auditing for GMP Compliance During COVID-19: Challenges and Opportunities

Gina M. Reo

Recorded Duration : 75 Minutes

Extractables & Leachables in Drug Development

Dr. Stefano Persiani

Recorded Duration : 60 Minutes

21 CFR Part 11 - Electronic Record and Signature Validation

Edwin Waldbusser

Recorded Duration : 60 Minutes

Software Validation Utilizing Principles of Lean Documents and Lean Configuration

Jose Mora

Recorded Duration : 90 Minutes

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