Category: GMP

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CGMP’s – Why Are We Still Getting It Wrong?

Presented by Karen Zimm, Associate Director for Janssen Pharmaceuticals and Renée Phillips, Associate Director of Global Regulatory Affairs at Janssen Research & Development Top Reasons to Attend: • What does FDA continuously cite on 483?• Why does industry make the same mistakes over and over?• Possible systemic reasons• Contributing factors CGMP’s – Why Are We […]

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Quality Management System (QMS) Inspection Readiness – Five Best Tips

Pharmaceutical Management System (PQS) is the cornerstone of pharmaceutical development and commercialization, and quality inspection will identify the weakness of the organization.  This session will introduce the PQS and five best tips to help the organization ready for a quality system inspection.  The following topics will be discussed:-Structure of the Quality Systems as per ICH […]

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Creating & Executing a Talent Plan with Job Role Clarity

Your ability to hire, train, inspire, and retain proficient staff in all departments will either propel your site to success or leave you stranded short of your operational goals.In our journey through the steps to bridge the chasm from Project mode to Operational Readiness, we arrive at the point where we must prepare to staff […]

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A Science and Risk-based Approach for Quality Systems Operations

You Can’t Distance From QualityPharmaceutical manufacturing companies are essential businesses in the current global environment of pandemic response; the products supplied are critical to the care and wellbeing of patients around the world. Continuing to operate in a controlled manner, following their Quality Systems, and producing safe and effective products are a significant challenge with […]

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“Live Review” During Inspections – Is your team prepared?

During this session we will introduce the “Live Review” inspection technique and discuss its use in recent inspections.  Along with this technique comes several challenges, including preparing your System Owners, Subject Matter Experts (SMEs) and Inspection Staff.  This session will offer suggestions on how to best prepare your teams, including a review of Warning Letters, […]

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