Skills for Job Success: ISPE Training, 17-20 Nov., San Diego, USA

 

Gain industry-specific knowledge on GAMP® 5, HVAC, cleaning, auditing for GMP, commissioning and qualification, HVAC, validation, and more, at ISPE San Diego classroom training. Instructors provide the know-how you need for job success today and in the future. Details and online registration at www.ISPE.org/sandiegotraining. From each course, take back to work:   Biopharmaceutical Manufacturing Facilities (Includes Webinar) Insight on controlled processing, primary and secondary segregation, personnel flow, and single product versus multiple product manufacturing for facilities that manufacture biopharmaceutical products   Biopharmaceutical Manufacturing Processes: A Comprehensive Overview (Includes Webinar) Tools to interpret, analyze, and evaluate biotechnology process information, guidelines for estimating capital and operating costs, parameters for scale-up and scale-down, and critical factors for developing a viable manufacturing process   Auditing for GMP How to evaluate information to prevent problems, effectively evaluate audit report findings, involve management in follow-up activities, and formulate effective questions to conduct audits   Application of Commissioning and Qualification (Includes Webinar) Ways to perform impact assessments, formulate an integrated C&Q strategy using test plans, prepare an outline of the qualification protocol based on actual design, execute an effective enhanced design, and develop a content outline of a commissioning and validation master plan   HVAC for Pharmaceutical Facilities  How to identify critical and noncritical parameters affected by HVAC and how to control them, and HEPA filter theory — application, monitoring, testing and repair, and typical designs for bulk, oral solid dosage, sterile, biopharmaceutical, packaging, and warehousing operations   Basic Principles of Computerized Systems Compliance (GAMP® 5)  Principles of computer systems compliance process, including a scaleable and efficient system lifecycle, quality risk management applying ICH Q9, GAMP 5 Guide basics, supplier assessment, and selection of specification and verification activities   Cleaning Validation Principles How to identify and characterize potential residues including product, processing aids, cleaning agents, and adventitious agents, apply appropriate analytical methodology for selected residues, determine suitable sampling techniques and sampling locations presenting a challenge to the cleaning process, calculate residue limits to meet regulatory requirements, create validation protocols, manage challenges of multi-product, and comprehend pitfalls inherent in cleaning after the production of biopharmaceutical products Sponsorship opportunities available . For more information, contact Dave Hall at tel: +1-813-739-2274; email dhall@ispe.org, or Karen Newhouse at tel: +1-813-960-2105, Ext. 254; email knewhouse@ispe.org.

 

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