BIOTECH 2012 - 2-day In-person Seminar - Key GMP Systems in Pharmaceutical and Biotech Labs

Website http://www.complianceonline.com/ecommerce/control/seminar?product_id=80006SEM&?channel=ourglocal | Edit Freely

Category FDA requirements; OOS Investigations; CAPAs; Equipment Qualification; Biologics Stability Programs; ICH; WHO; Stability methods; GMP systems; Pharma GMP system; Biotech GMP system

Deadline: May 10, 2012 | Date: May 11, 2012-May 12, 2012

Venue/Country: Boston, U.S.A

Updated: 2012-03-28 18:45:14 (GMT+9)

Call For Papers - CFP

The FDA has ramped up surveillance and we have seen an increase in the number of warning letters issued to manufacturers. We have seen a corresponding increase in GMP upgrade projects in the industry.

This workshop will provide the audience with information to perform a gap analysis of their existing GMP systems by reviewing the major areas of concern listed by FDA inspectors. The systems covered will include FDA requirements for OOS Investigations, Pharmaceutical and Biologics Stability Programs and Method Validation and Handling Regulatory Inspections.

Who will Benefit

- QC chemists, supervisors and managers

- R&D chemists, supervisors and managers

- QA Managers and personnel

- Regulatory Affairs personnel