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At the conclusion of this session, participants will be able to:
Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E 2500-07 ensures GMP facilities and equipment are: "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. This webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle
Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory.
Steven J. Wisniewski is Senior Associate and Director of Compliance for Integrated Project Services (IPS), a full-service engineering firm specializing in the delivery of technical complex projects, and that offers complete design/build, commissioning, validation and FDA compliance services for the pharmaceutical, biotech, health care, and specialty manufacturing industries. Wisniewski has more then 30 years experience in the pharmaceutical, biotech, and device industries. Currently, Wisniewski is chairman of the ISPE Community of Practice for Commissioning and Qualification, and is on the ISPE task team developing the revised ASTM Verification Standard and the new C&Q Baseline® Guide: Science and Risk-Based approach for the Delivery of Facilities, Systems, and Equipment, Volume 12 to support implementation of ASTM E 2500.
C&Q, API, CU, GAMP, HVAC, OSD, PM, and SPP
This Webinar relates to the following CPIP™ Knowledge Elements: