Validation Week Happenings

摘要

Ivt's 17th annual Validation Week took place in Philadelphia, PA on October 24 through October 26. Highlights from the conference included presentations by FDA representatives and industry experts as well as interactive workshops. Topics included process validation, writing validation documents, qualifying virtual networks, change management, method validation, FDA inspections, and risk management. Richard L. Friedman, Director of the FDA's Office of Manufacturing and Product Quality Office of Compliance, Center for Drug Evaluation and Research (CDER), presented an overview of FDA's process validation guidance. Friedman discussed the history and applicability of the guidance as well as the lifecycle approach to validation. FDA's Karyn M. Campbell, Director, Investigations Branch, Philadelphia District, gave an FDA investigator's insights on audits, FDA-483s, warning letters, and common mistakes companies make both in their processes and dealings with FDA inspectors. Karyn presented the top 10 drug observations, which included lack of quality oversight, manufacturing process validation, and training deficiencies. Some examples of company quality oversights included no quality unit, procedures not followed, failure to enforce the microbiology laboratory's responsibility to accept or reject raw materials, and failure to review and approve validation protocols.