Critical Thinking & Periodic Review
The drive within life sciences to improve patient safety and product quality, and provide value to society, while reducing costs requires constant and effective innovation. However, because the pharmaceutical industry operates in a highly regulated sector, some practitioners may apply unthinking, prescriptive, and rigid approaches that are not commensurate to the needs of the process, the nature of the system, and the real risk to the product and the patient.
The NEW GAMP Good Practice Guide on Enabling Innovation will be presented during this webinar.
Our speakers are:
- Tom De Rudder (Systems Team Lead at Novartis)
- Thierry Provinciael (Consultant Life Science Industry)
Tom De Rudder will discuss the new ISPE GAMP® GPG Enabling Innovation. Thierry Provinciael will guide you through the subject of Applying Critical Thinking on Periodic Review.
We will close-out with an interactive discussion session, where you can share your ideas and opinion about this subject.
Attending the webinar is free for ISPE members. Non-members have to pay a fee of only €10,-. Registration is required.
We kindly ask all participants to create a (free) account on https://miro.com/login/ to participate in the discussion.
|Event Date||07-Dec-2021 15.00|
Welcome & Introduction
GAMP COP Benelux
New ISPE GAMP® GPG supports Innovation in Life Sciences Industry (Tom De Rudder - ISPE GAMP CoP Europe, Vice-Chair)
In September 2021 ISPE released The ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management. The first such guidance to discuss Critical Thinking, Agile Software Development and IT Service Management in relation to the life sciences industry, applying ISPE GAMP®5 principles and current good practices to promote technology and innovation. During this presentation, some takeaways will be given about critical thinking to promote innovation and advancement.
Apply critical thinking to Periodic Review - Thierry Provinciael
During this presentation, Thierry will provide some more insights in how critical thinking can be applied to periodic review. He will present an example from a previous project where critical thinking was systematically used to determine the need and frequency for audit trail review.
Interactive workshop - Thierry Provinciael
During this interactive workshop we want to give all participants a chance to share their experience and insights in how critical thinking can be applied to periodic review. Participants will be able to provide input and discuss using a big virtual whiteboard. We will use Miro for this interactive session. We ask all participants to create a (free) account on https://miro.com/login/
Wrap-up Interactive workshop - Thierry Provinciael
Summary of the results of the interactive workshops.
ISPE GAMP CoP Europe, Vice-Chair
Tom De Rudder has +20 years experience in Pharmaceutical Industry with expert knowledge in Computerized Systems GxP requirements & validation. He works as Site eCompliance/Computerized Systems Team Lead at Novartis. He drives continuous improvement to meet and sustain compliance, also active as a volunteer in ISPE GAMP Community of Practice (GAMP Europe, GAMP Benelux, SIG Data Integrity, Pharma 4.0.).
Freelancer supporting Pharma and Medical Device Industry with CSV and project management.
Experienced Senior Compliance Engineer and project manager with a demonstrated history of working in the Pharmaceutical industry. Skilled in Computerized System Validation, Requirements Analysis, data integrity and GxP. Strong quality professional with a Master in Industrial Sciences: Biochemistry from De Nayer Instituut.