Data Integrity: The Roadmap to Compliance
Wednesday, September 25, 2019
10:30 – 11:30 am, followed by Q&A
Presenter: Cindy Lipton, Quality Assurance Consultant, MWA Consulting, Inc.
Cost: No Charge
Registration required. Register 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.