Technical conference looks at latest FDA rulings

Does the relaxation by FDA change a plant strategy on CFR and GMP compliance? How much risk should pharmaceutical plants take? ISA answers these and more questions at San Jose 9-10 December 2003

Does a relaxation of FDA regulations change a plant strategy on CFR and GMP compliance? How much risk should pharmaceutical plants take? ISA answers these and many other questions at the 21 CFR 11 and GMP Compliance Technical Conference in San Jose, California, 9-10 December 2003.

This interactive, two-day conference addresses both the procedural and technological issues of 21 CFR 11 and GMP.

Presentations focus on the risk-based approach that offers plants a chance to build a compliance plan that suits them but simultaneously makes audits more subjective.

Much is left to interpretation in the FDA reissue of Part 11.

Presenters at this conference help clarify the right moves a company should make.

On Tuesday, 9 December, conference speakers discuss the FDA rules and how a company should go about developing the best approach.

Presentations continue on Wednesday, 10 December, with discussions on process controls systems as well as preparing for an FDA audit.

In addition, a product showcase features some of the latest technology and services to help attendees meet their compliance needs.

The ISA 21 CFR 11 and GMP Compliance Technical Conference takes place at the DoubleTree Hotel - San Jose, 2050 Gateway Place, San Jose, California in the USA.

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