Avoiding Failure to Investigate - Observations by Conducting Effective Investigations

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:

Attendees will learn

• 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.

Who Will Benefit:

This webinar will provide information to regulated industry including pharmaceutical, biotechnology, responsible for the manufacture of cGMP products.  Those functional roles that would derive the most benefit from this webinar include:

• VPs of Quality, Operations or Manufacturing
• QA Managers/Directors
• QC Managers/Directors
• Quality Systems Personnel
• Operations or Manufacturing Managers/Directors

Instructor Profile:

Felicia Ford-Rice, is a Principal Consultant with PAREXEL Consulting, a division of PAREXEL International, specializing in Strategic Compliance.  Felicia has over twenty years experience working in Research and Development, Regulatory Affairs and Quality Assurance roles for Academia, the US Government, Vaccine and Pharmaceutical manufacturers.  In previous roles she has led the creation of the following quality system elements: deviation/CAPA, investigation, effectiveness checks, management review processes, product disposition/ release, aseptic processing support, change control, product complaints, product recalls, quality agreements, EM trending, APRs, controlled documentation management, internal/external audits, supplier qualification, MRB, CRO/CMO oversight, regulatory authority inspection readiness, anti-counterfeiting communications.  Felicia has also trained and directed the GMP, GLP, GCP and regulatory inspection readiness training of multidisciplinary staff, taught graduate courses on Regulatory Affairs and Quality Assurance topics for Northeastern University.  She has authored technical reports, co-authored or contributed to abstracts and scientific papers published in peer review journals and presented at scientific symposia.  Felicia has also served on the SCDM Editorial Board, and the PDA Annual Meeting Program Planning Committee and currently supports the HBA Membership and Marketing Committees.  She is a member of PDA, RAPS, DIA, and HBA and holds a RAC Certification.

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