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|10 - 9999|
GAMP Classification for Pharma Equipment and Software Systems: Maximizing Utility, Minimizing Risk
With added emphasis on science based risk management and the reliance on technical experts to assist in the assessment process pharmaceutical manufacturing is becoming increasingly automated. That means Good Automated Manufacturing Practice (GAMP) is more relevant than ever. As the hardware and software evolves, GAMP evolves accordingly.
Generally, the more specialized the software, the greater the risk, particularly from user error. However, opportunities now exist to leverage contributions from suppliers and vendors in the implementation of regulated computer systems.
With proper controls and oversight this can enable many life cycle and validation activities to be completed more efficiently while maintaining a high level of compliance.
Mr. Gaurav Walia will walk you through the history of GAMP, including the transition to GAMP 5 and the changes in categorization. He’ll detail the top three challenges in implementing GAMP, the typical issues of legacy systems, key laboratory examples, and the top trends in consent decrees related to GAMP. He’ll conclude with a discussion of upcoming GAMP-related publications expected from the FDA and others.
At the conclusion of this presentation you’ll have the foundation for developing and establishing a compliant and effective computer system validation framework.
Don’t miss out on critical information you need to ensure your manufacturing meets 21st-century standards — you can’t afford it.
Mr. Gaurav Walia, M.S. has over 17 years of Pharmaceutical experience with careers at Monsanto/Searle, Pfizer/Oread, Forest Laboratories, and others while also serving as a Pharmaceutical Consultant in various disciplines from Quality Systems, R&D, CD, CSV, Vendor Certification etc. Mr. Walia has managed various technical, quality and compliance groups, such as but not limited to, Pharma R&D, Laboratory Information Management Systems (LIMS), Metrology, Quality Control (QC), Materials Import and Export, Safety, New Facility Design, Validation and Commissioning, Capital Budget (Instrument and Equipment Acquisition from R&D to Commercial, Operating Budget (All Service contracts), Regulatory Compliance, etc. Mr. Walia's diverse, multi-disciplined background has yielded years of success towards internal audit excellence and successful remediation projects. He has well over 100+ regulatory audits with domestic and international regulatory agencies. Additionally, Mr. Walia's experience spans many product lines such as liquids, solids, patches, creams, antibiotics/aseptic processes, medical devices, and biologics. He also has experience with nutritional, OTC, generic and proprietary/branded products.
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