Join Tanya du Plessis and Tony Hewer as they a look at an innovative approach to solving the mysteries of regulatory guidance around audit trail reviews:
• What do regulations (21 CFR Part 11) say about audit trail reviews?
• What’s the purpose on audit trail review?
• How to prove you conform with GCP and ER/ES guidance?
• How to do audit trail reviews meaningfully, quickly and effectively
During the webinar we will do a deep dive into industry and regulatory requirements, as well as Bioforum’s approach to solving the challenges. You will have better insight into guidance provided around audit trail reviews, as well as how to illustrate conformance through quick, effective reviews, that will save you time and effort.
Tap into the expertise of these well experienced presenters to solve the problem within your own organization!
Featured Presenters
Tanya du Plessis
Chief Data Strategist & Solutions Officer
Tanya du Plessis has more than 18 years of experience as a manager of various data management operational teams, and she is a certified clinical data manager and project management professional. She holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State.
Tony Hewer
Founder & Director, Cepheus Consultancy Limited
A highly successful IT professional with 30+ years experience in the global commercial, financial and pharmaceutical marketplaces, seeking new challenges that leverage teamwork, leadership and consultancy skills. Enjoys all aspects of dealing with people on such challenges and in ensuring that technology and business professionals work in harmony to achieve their objectives.
Share with friends: