TAMPA, FL, USA–05 July 2005–Three different sessions addressing Good Automated Manufacturing Practice (GAMP) issues will highlight ISPE’s Chicago Training Series, scheduled for 22-25 August at the Eaglewood Conference Resort and Spa in Itasca, Illinois. ISPE provides a wide range of Member-driven educational programs and resources to pharmaceutical industry practitioners worldwide, and is the originator and owner of all GAMP programs.
The Chicago Training Series will open on 22 August with a meeting of the GAMP Americas Forum, a one-day session led by Arthur (Randy) Perez, Executive Expert, QA, Novartis Pharmaceuticals Corporation. The GAMP Americas Forum is open to all pharmaceutical manufacturing professionals, and attendees will have the opportunity to participate in the creation and sharing of computer systems validation and compliance guidance, recommendations, and example practices.
The GAMP Americas Forum will be followed over the next four days by 10 training sessions including a course based on ISPE’s upcoming GAMP Good Practice Guide: IT Infrastructure Control and Compliance, and one focusing on the basics of computer systems validation using GAMP 4. Other courses will focus on such topics as pharmaceutical GMPs, water systems, cleaning, technology transfer, and biopharmaceutical process development. For complete descriptions of each course and to register on-line, visit www.ispe.org/goto_chicagotraining.
ISPE Chicago Training Series: Schedule at a Glance
* GAMP Americas Forum
* Cleaning Fundamentals for the Pharmaceutical Industry
* GMP Fundamentals for the Pharmaceutical Industry
* Pharmaceutical Water Generation Systems (Includes Webinar)
* Technology Transfer for Finished Dosage Forms, Oral Solids, and Sterile Liquids
* GAMP Good Practice Guide: Infrastructure
* Basic Principles of Computer Systems Validation Using GAMP 4
* Beyond the Fundamentals-An In-depth Review of GMP for the Pharmaceutical Industry
* Biopharmaceutical Process Development (Includes Webinar)
* Cleaning Validation Principles and Practices
* Pharmaceutical Water Storage, Distribution, System Operation and Validation
GAMP is a product of the GAMP Forum, a technical sub-committee of ISPE whose mission is to promote understanding of the regulation and use of automated systems within healthcare industries. The GAMP Forum’s strategy for computer systems compliance is described in the GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacture – GAMP 4, an ISPE technical publication which provides a basic framework for validation and addresses considerations unique to particular classes of systems. Since the publication of GAMP 4 in late 2001, several GAMP Special Interest Groups (SIGs) have developed Good Practice Guides addressing these special considerations and systems classes. The GAMP Good Practice Guides include:
* GAMP Good Practice Guide: Calibration Management
* GAMP Good Practice Guide: Validation Process Control Systems (VPCS)
* GAMP Good Practice Guide: Legacy Systems (Published in Pharmaceutical Engineering, Vol. 23, No. 6)
* GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures
* GAMP Good Practice Guide: Validation of Laboratory Computerized Systems
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for nearly 23,000 pharmaceutical manufacturing professionals in 80 countries. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida; an Asia Pacific office in Singapore; a European office in Brussels, Belgium; and Affiliates and Chapters in 18 countries around the world. Visit www.ispe.org for additional Society news and information.
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GAMP is a registered trademark of ISPE.
any training related with validation/qualification in the end of dec-2013.
am waiting ur response.