GAMP5® Industry Forum in Boston, October 2-3 2008
“Best Practices for Qualification of Laboratory Equipment Utilizing GAMP5, ASTM E2500 – 07 and USP 1058 AIQ” will be presented by Joe Tehrani, PhD., at the GAMP5® Industry Forum in Boston, October 2-3 2008.
The forum, “Implementing and Utilizing Risk Management and GAMP5,” features industry leaders from PerkinElmer, Abbott Laboratories, Rockwell Automation and others.
Dr. Tehrani from PerkinElmer will review qualification of laboratory instruments based on GAMP5, ASTM E2500 – 07 and USP <1058> Analytical Instrument Qualification (1058 AIQ), noting the similarities among the guidelines and addressing a streamlined approach that satisfies all regulatory guidelines.
Specifically, he will address:
- Understanding GAMP5, ASTM E2500 – 07 and USP 1058 AIQ.
- The similarities between the three guidelines.
- Integration of GAMP5 with ASTM E2500 – 07 and USP 1058 AIQ
- Qualification of various lab instruments, including HPLC, LCMS, GC, GCMS and other common analytical instruments.
- The cost/benefit analysis of multivendor lab instrument qualification by qualified independent services providers, detailing the benefits of protocol uniformity and a streamlined approach to qualification.
Dr. Tehrani’s presentation will include an overview on crafting an efficient and cost-effective compliance program that can satisfy each of the guidelines:
GAMP5
The newly released GAMP5 guidelines feature a risk-based approach to validation of GxP computerized systems, including the entire lifecycle of an automated system and its applicability to:
- Information systems
- Lab equipment
- Integrated manufacturing systems
- IT infrastructures
ASTM E2500 – 07
ASTM E2500 – 07 is the standard guide for “specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment.” The guide covers a variety of devices, including laboratory equipment.
USP <1058> Analytical Instrument Qualification (1058 AIQ)
USP 1058 AIQ is the latest in a series of GxP guidelines for qualification of laboratory instruments and describes a meaningful and straightforward approach for qualification of different lab instrument categories while also differentiating between qualification and validation terminology.
The GAMP5® Forum, organized by SWE Enterprises, will be held at the Tremont Marriott in Boston, MA, October 2-3, 2008. To register call 813-655-7788 or email registration@sweinc.biz. For more details about the forum, visit http://www.sweinc.biz.
For more information about PerkinElmer’s multivendor services, including qualification, visit the PerkinElmer OneSource website.