Webinars and Podcasts
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Inhalation Drug Development Process Overview
Wednesday, May 19, 2021
Presented by Aditya Das, Ph.D., MBA
Webinar recording will be posted soon – email to request
Inhalation drugs offer a targeted approach in the fight against various respiratory diseases. Utilizing existing technologies with 505(b)(2) regulatory pathways, the industry is poised to move into a new phase of development. This webinar is meant to give an overview of the history of the inhalation drug market as well as to look at the potential for new growth and applications.
Remote Auditing: Best Practices and Practical Suggestions from MWA
Wednesday, April 21, 2021
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Covid-19 taught us a few things about remote auditing. We’ll share how to address challenges as well as plan for best results. While the COVID-19 pandemic has disrupted our normal auditing processes due to the current on-site restrictions, our industry has (not surprisingly) adapted with new and improved ways of auditing to ensure we can continue to provide proper oversight of our contract services suppliers. MWA’s experienced auditors have shared their remote auditing experiences and best practices with us, which you will hear about during this webinar. One of our expert auditors will be available for questions at the end of the presentation. Training certificates will be available upon request for all verified attendees.
What to Expect in an FDA Inspection: CPGM-Updated PAI Guide
Wednesday, January 15, 2020
Download the presentation (PDF)
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
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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.
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