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What to Expect in an FDA Inspection: CPGM-Updated PAI Guide
Free Webinar hosted by MWA
Wednesday, January 15, 2020
10:30 – 11:30 PST followed by Q&A
To watch the recorded webinar, click on the image and then the arrow in the lower left corner to begin playback. There will be a brief delay.
What to Expect in an FDA Inspection-Compliance Program Guidance Manuals: Updated Pre-Approval Inspections (PAI) guide (CPG 7346.832)
Understanding FDA’s expectations during an inspection is key to inspection readiness and maintaining a state of control for all your operations that are subject to the Federal Food Drug and Cosmetic Act (FFDCA) and the Public Health Service Act (PHSA) and the regulations and rules in place to enforce these Federal Laws.
The FDA performs risk-based inspections for products in development and those on the commercial market, whether they are manufactured in-house or outsourced to CMOs. FDA inspections ensure products comply with cGMP and that reliable data are submitted to demonstrate that drugs and devices are safe and effective.
The FDA has published CPGMs (Compliance Program Guidance Manuals) for FDA Inspectors to follow when conducting inspections of Drug and Device establishments
MWA will provide 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
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. ICH E6(R2) was finalized in February 2018.
MWA Consulting, Inc. will provide 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.
This webinar will also cover the changes to Investigator responsibilities related to delegated functions, and Sponsor responsibilities for quality management and a risk-based approach and new requirements related to Essential Documents. This training provides an opportunity for you to keep up with changes and stay current with industry guidance and regulations.
Data Integrity: The Roadmap to Compliance
Wednesday, September 25, 2019
Watch the webinar here:
Even with increased attention to Data Integrity, regulatory inspections continue to find many Data Integrity issues like 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.
MWA will provide a roadmap to understand the responsibility of companies to implement, train and maintain Data Integrity through Management Governance, Culture, Risk Assessments, Data Governance, Technology and Validation, Procedures and Processes.
In this webinar, MWA will cover regulatory guidance, review FDA Warning Letters, and ALCOA+ and provide recommendations for meeting your compliance needs.
About the Presenter: During her over 20 years of experience in a regulated industry in small and large company settings, Cindy Lipton has managed Quality Systems development and implementation. In virtual company settings, Cindy implemented vendor management and audit programs. She has led the QA/QC functions for pharmaceutical development and manufacturing and has hosted FDA and various Health Authority inspections.
Implementing a Phase I Quality Management System (QMS)
Wednesday, July 17, 2019
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.
MWA will help you understand the important procedures you will need for a Phase I product, and provide recommendations for meeting your compliance needs.