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GMP, GLP or ISO 17025: How Do These Apply to Outsourced Analytical Testing?


Joe Grappin (Account Executive, EAG Laboratories)

Location: Tech Theater, Booth 637

Date: Wednesday, February 7

Time: 1:30pm - 2:15pm

Pass Type: Expo (Free), Conference (Paid) - Get your pass now!

Free Content & Activities: Tech Theater

Vault Recording: Not Recorded

How do you know the appropriate quality standards for outsourcing analytical projects to support medical device product development? Should you require a GLP or GMP regulated laboratory? What does an ISO 17025 certified analytical laboratory mean? Your Quality Assurance department may dictate multiple tiers of quality requirements. However, certain requirements may limit the types of analysis performed, or even result in lengthy investigations on investigational results. This presentation compares and contrasts the different quality standards from FDA, OCED and ISO, to help you understand how these quality standards apply to analytical testing for medical device development.