Effective Investigations & Corrective Actions for Pharmaceutical & Biopharmaceutical Industries
|Event Date/Time: Sep 20, 2004||End Date/Time: Sep 21, 2004|
- GMP requirements for failure investigation in the US, EU, and Canada
- Investigation of Failures and Quality Events by Regulatory Agencies
- Investigation of Out-Of-Specification (OOS)
- Non-Conformance Report (NCR)
- Effective "Root Cause" Analysis
- Essentials of Corrective Actions and Preventive Actions (CAPA) program
- Process Deviation Investigation
- Documentation of Investigations
- Tools for Effective Investigations
- Trending - Tools for Improvement
Workshops & Case Studies on:
- Evaluating Laboratory Out-Of-Specification Results
- Manufacturing Failures
- Manufacturing Deviations
Once again in the pursuit of the excellence and because of popular demand, the International Pharmaceutical Academy (IPA) is proud to bring you the “Effective Investigation & Corrective Action” program.
What do you do when the following 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
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.
Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory agencies' inspections. The agencies recognize that failures are a part of business but also expect comprehensive investigations, the application of scientific judgment, and learning from the experience and permanent solutions to the problems identified.
Providing a step-by-step foundation for conducting investigations, this training program highlights tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a such way 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 determine proper solutions to apply adequate corrective action/s.
Learn to avoid common obstacles to success and practice conflict resolution skills. Take advantage of this unique opportunity to participate and learn from your peers in this one and a half-day case study and workshop outlining tips and techniques and expert solutions to improve failure investigations, identify proposed corrective action, and ensure successful implementation and closeout.
Who Should Attend?
This program is specially designed for Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Vitamins, Herbals, and allied industries with daily responsibilities in the following areas:
- Quality Assurance
- Quality Control
- Analytical Laboratories
- Compliance Auditing
- Regulatory Affairs
- Change Control
- Documentation and Technical Writing
- Contract Services