EFFECTIVE INVESTIGATIONS What to Do When the Unexpected Happens! - Proper Investigation of Quality Events

Why Should You Attend:
When unexpected events happen – you cannot follow an SOP and need to deviate from it, or you obtain an out-of-specification test result, or your supplier’s raw materials marginally fails specification and you desperately need the material – what do you do? A few years ago, the standard reaction to an unexpected event was either to ignore it, it might go away, or to fix it. Today such reactions are unacceptable when working in a GMP environment. Not only do you need to investigate the event to determine what happened, but you need to figure out why the event happened, and then to resolve the event in a manner that prevents its recurrence. Not only is this sound GMP, it also makes good business and economic sense.

This course is teaches tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a manner such that they stay resolved in a GMP compliant manner. The course will examine actual situations as case studies, with students guided in effective investigation resolution, and required to perform effective investigations, and determine proper solutions to effect proper corrective action.

Areas Covered in the seminar:

• GMP requirements for failure investigation in the US, EU, and Canada.
• How do the GMP authorities want you to investigate failures and quality events?
• Being “In Control” – Essentials of a Corrective Actions and Preventive Actions (CAPA) program.
• “Root Cause” – what is it, and how to you find it.
• Key Considerations in effective “Root Cause” and CAPA Analyses.
• FDA’s Out-Of-Specification Guidance, and US requirements for effective investigations.
• Out-Of-Specification (OOS), Out-Of-Trend (OOT), Out-Of-Expectations (OOE) incidents.
• Tools for Effective Investigations:
  • Ishikawa (Fishbone) Analyses
  • Pareto Analysis
• Documentation of Investigations.
• Case Studies:
  • Laboratory Out-Of-Specification Incidents
  • Manufacturing Failures
  • Manufacturing Deviations

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• End-users responsible for applications that need to be validated
• QA managers and personnel
• Production Managers and production staff
• QC Lab Managers and QC analysts
• Consultants
• Quality system auditors

Instructor Profile:
Michael Anisfeld, is senior consultant for Globepharm Consulting specializing in GMP/Quality activities for the healthcare manufacturing industries. In his current position he numbers among his clients United Nations Agencies, national regulatory agencies (including the US-FDA) and more than 200 pharmaceutical, medical device, biotechnology and bulk pharmaceutical companies in North America, Europe and Asia. Mr. Anisfeld has established and directed quality control, quality assurance, production and materials management functions in the industry. He has instituted innovative, cost-effective auditing Programmes for his clients, ensuring that they pass regulatory inspections the first time. With over twenty-five years expertise in the healthcare industry, Mr. Anisfeld has held senior management positions in international technology transfer, quality assurance, quality control and production.

In the course of his career, he has designed pharmaceutical, medical device and bulk pharmaceutical chemical facilities in seven countries. A member of the faculty of the University of Illinois, where he lectures in pharmaceutical technology, Mr. Anisfeld holds higher degrees in Pharmaceutical Technology (M.Sc.), Management (MSM) and Business Administration (MBA). An active member of many European and American regulatory and technical associations, he has served on the Board of Directors of the Parenteral Drug Association (PDA) and been chairman of its quality control and aseptic processing task groups. He currently serves on the FIP Task Force on Counterfeit Drugs and other international industry forums. An acclaimed international lecturer on the subject of GMP and quality topics, Mr. Anisfeld is also a prolific author on these subjects. He is the editor and author of many texts, including: International Drug GMPs, International Device GMPs, and Guide to FDA Pre-Approval Inspections, Sterile Pharmaceutical Manufacturing, and PDA’s monograph Validation of Aseptic Processing of Liquid Drug Products.