ICH Q12 Guidance and PIC/s Draft Guidance on Effective, Risk-Based Change - Karen Ginsbury
Managing Change in Process and Product Lifecycle:
ICH Q12 Guidance and PIC/s Draft Guidance on Effective, Risk-Based Change - Karen Ginsbury
PPS Webinar, Wed, September 09, 2020
- ICH Q12 Technical and Regulatory Considerations For Pharmaceutical Product Lifecycle Management (Adopted 20 November 2019). This guideline provides a supposedly harmonized framework to facilitate the management of Post-Approval CMC Changes in a predictable and efficient manner over the Product Lifecycle.
- PIC/S Recommendations: How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management. The document provides guidance on the Change Management Process - from Change Proposal, through Assessment, Planning, Implementation, and including Change Review and Effectiveness Checks
- CAPA and Continuous Improvement are inseparable expectations from both the above guidances and is inseparable from Change Management.
- And then along came COVID which has changed every rule in our book, without reading our Change Control SOP!
1. What are we doing, what are regulators doing and is there ANY room for flexibility (not one of the “strengths” or GMP interpretation by regulators)
2. How do we move forward to effective, essential and swift, Change Management as we transition back into post-COVID production?
This webinar will review the two Guidance Documents, summarizing key points and distilling the outcome as a checklist of points to consider in a Gap Analysis and if needed upgrade of your existing change procedures. In addition, we will also identify some COVID Audit points, allowing participants to ask questions and clarify their issues and preparation for 2020 / 2021 Product and Process Management in the shadow of the virus.
PPS Workshop Leader, Karen Ginsbury, B.Pharm, M.Sc, has over 30 years of experience in the pharmaceutical industry. With her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd., since the last 20 years, works with Pharmaceutical, Biotech and API Manufacturers to assist them in resolving Compliance Issues with Regulatory Authorities, in Setting-Up, Maintaining and Upgrading or Improving their Quality Systems, performing Audits at Vendors, Contract Manufacturers, Laboratories as well as helping clients successfully prepare for USFDA, Health Canada, EU and local Regulatory Inspections. Karen regularly lectures worldwide on Quality topics and is renowned for her lively and engaging style of presentation. A member of PDA's prestigious Regulatory Affairs and Quality Advisory Board (RAQAB), and co‐chair of PDA's Special Interest groups, Karen has won several Awards from IVT and PDA honoring her contribution to international activities