Webinars and Podcasts

Upcoming Webinars

DateTopicRegistration
Q4 –2020Overview of Cell Therapy/Gene Therapy Regulations US vs. EU GMP DifferencesSign-Up for E-mail Updates
Q1 –2021Computer System Validation OverviewSign-Up for E-mail Updates
Q2-2021 GLP Comparison of US vs. EU GMPs: Differences and SimilaritiesSign-Up for E-mail Updates

 

Past Webinars

 

What to Expect in an FDA Inspection: CPGM-Updated PAI Guide
Wednesday, January 15, 2020
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The FDA has published CPGMs (Compliance Program Guidance Manuals) for FDA Inspectors to follow when conducting inspections of Drug and Device establishments. In this webinar, MWA provides an overview of these manuals, where to find them and how to use them to prepare for FDA inspections of your facility or operations.

 

Keeping up with Regulations: Good Clinical Practice ICH E6(R2)
Wednesday, November 13, 2019
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For over 20 years, the Good Clinical Practice Guidance document ICH E6 (R1) has been the guiding star for the conduct of clinical studies to ensure data integrity and patient safety. Since the ICH E6 (R1) was finalized in May 1996, the industry has changed from largely paper-based to electronic records, and clinical studies have become larger and more complex. With the shift to risk-based quality management, a need arose to modernize and update the GCP guidance. In this webinar, MWA provides an overview of the changes in the ICH E6(R2) integrated addendum, including the new additions to the glossary of terms defining a Certified Copy, Monitoring Plan and Validation of Computerized Systems.

 

Data Integrity: The Roadmap to Compliance
Wednesday, September 25, 2019
Download PDF of presentation (PDF)

Even with increased attention to Data Integrity, regulatory inspections continue to find many Data Integrity issues, such as failure to contemporaneously record information, failure to investigate failed test results, use of shared passwords, lack of audit trails, and failure to review electronic data. In this webinar, MWA will cover regulatory guidance, review FDA Warning Letters, and ALCOA+ and provide recommendations for meeting your compliance needs.

 

Implementing a Phase I Quality Management System (QMS)
Wednesday, July 17, 2019
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If your company is involved in development or manufacturing for drugs, biologics, and/or medical devices, you must ensure compliance with regulatory requirements for managing quality. Implementation of a Quality Management System (QMS) must be appropriate for the phase of your product development. In this webinar, MWA will help you understand the important procedures you will need for a Phase I product, and provide recommendations for meeting your compliance needs.

Podcasts

 

Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA Consulting

 

Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA Consulting

 

Quality Agreements with Lisa Helmonds from MWA Consulting

 

Quality Culture with Lisa Helmonds from MWA Consulting

 

Management Review and Quality Metrics with Lisa Helmonds from MWA Consulting

 

Investigation Deviations and Non-Conformances with Lisa Helmonds Vice President from MWA Consulting