Avoiding 'Failure to Investigate' - Observations by Conducting Effective Investigations 2011

Why Should You Attend: The Current Good Manufacturing Practice for Finished Pharmaceuticals regulations of the US Food and Drug Administration require investigations to be conducted per 21 CFR Part §211.192 regulations.

Although this regulation has been in effect since 1978, organizations continue to struggle with the effective conduct and documentation of investigations to meet the expectations of regulatory authorities. An FDA guidance document regarding "Out-of-Specification Investigations" was finalized in 2006, but primarily covers the investigation of "chemistry-based laboratory testing of drugs regulated by the Center for Drug Evaluation and Research (CDER)".

Establishing an effective system of conducting investigations, to ensure compliance of the five manufacturing systems: production, facilities and equipment, laboratory controls, materials, packaging and labeling and the overarching quality system is an essential requirement for the manufacture and commercialization of all FDA regulated products.

This webinar will discuss five key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance.

Areas Covered in the Seminar:

• How to incorporate key attributes of effective investigations into the Quality System.
• The role of management in planning and documenting effective investigations and assuring cGMP compliance.
• How to strategically employ quality control tools in effective investigations.
• Ensuring adequate Corrective Action and Preventive Action Effectiveness checks and follow-up.
• Key cGMP Issues from Regulatory Authority Inspections programs.

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