Block Your Calendars - Wed, September 09, 2020

Meet Karen Ginsbury for a discussion on the “ICH Q12 Guidance and PIC/s Draft Guidance: Managing Change in Process and Product Lifecycle”

·        What are we doing v/s What are Regulators asking for? Is there ANY room for flexibility?

·        How do we move forward to effective, essential and swift, Change Management, especially, as we transition through the Covid-19 pandemic?

·        Do we need an upgrade of the existing Change Management Procedures?

Karen Ginsbury has been working with several renowned Industry-Regulator Forums world-wide on the Review of latest Guidances, their impact on industry and understanding of the Regulators’ perspectives.

During this webinar, participants will review the two guidance documents – ICH Q12 and PIC/S Draft Guidance on Change Management. Karen will be summarizing the key points and distilling the outcome as a checklist of points to consider in a Gap Analysis on Change Management. In addition, she will also identify some COVID audit points, allowing participants to ask questions and clarify their issues in preparation for 2020 / 2021 product and process management in the shadow of the virus.

Register Now! Call Shweta Tawde  M: + 91 9324052308 or Email on [email protected] 

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