Upcoming Events

Keeping up with Regulations: Good Clinical Practice ICH E6(R2) Feb 2018 Integrated Addendum
Free Webinar hosted by MWA

Wednesday, November 13, 2019
10:30 – 11:30 PST followed by Q&A

Register Here (Eventbrite)

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.

Past Events

Data Integrity: The Roadmap to Compliance
Wednesday, September 25, 2019

Watch webinar recording (external link)
Download PDF of presentation

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
Download Presentation (PDF)

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.