Event Date/Time: Sep 30, 2008
The course examines actual situations, guiding participants in effective investigation resolution and determining solutions to effect proper corrective action.
When unexpected events happenâ€”you cannot follow an SOP and need to deviate from it, or you obtain an out-of-specific action test result, or your supplierâ€™s raw materials marginally fail specific action and you desperately need the materialâ€”what do you do? A few years ago, the standard reaction to an unexpected event was to ignore it or make an attempt to quickly fix it. Today, such reactions are unacceptable when working in a GMP environment. FDAâ€™s strategy for GMP implementation for the 21st centuryâ€”part of its quality systems approachâ€”demand that proper investigations and corrective actions take place and be documented. Not only do you need to investigate the event to determine what happened, but you need to find out why the event happened and resolve it in a manner that prevents recurrence. Itâ€™s sound GMP, and makes good business and economic sense. A well-managed CAPA (corrective and preventive action) program not only provides effective and mandated regulatory compliance, but also yields enhanced productivity.
As part of FDAâ€™s â€œGMPs for the 21st centuryâ€ program, performing effective investigations into deviations and failures has become a key element of risk management and GMP improvement, and has become a key focus during regulatory inspections.This course teaches tools and techniques that can be employed to get to the root causes of unexpected quality events, and help resolve them in a lasting, GMP compliant manner.The course examines actual situations, guiding participants in effective investigation resolution and determining solutions to effect proper corrective action
Areas Covered in the seminar:
* EU and US GMP requirements for failure investigation
o How the GMP authorities want you to investigate failures and quality events.
o Effective investigations tools:
o Interview skills
o Detective skills
o Documentation skills
o CAPAâ€”corrective action and preventive action programsâ€”what they are, and what FDA wants from you
o Being in controlâ€”essentials of a CAPA program
o Root causes
o what they are and how to find them
o Key considerations in effective analysis and CAPA analyses
o When pursuit of 'root cause' is a waste of time
o Event and causal factors analysis
o FDAâ€™s out-of-specification guidance and US requirements for effective investigations
o Out-of-specification (OOS), out-of-trend (OOT), out-of-expectations (OOE) incident investigations Documentation of investigations
* Quality event definitions
o Tools for effective investigations:
o Ishikawa (Fishbone) analyses
o Pareto analysis
o Force field diagrams
o Six-Sigma analysis
o Kepner-TregoeÂ® analysis
o Tools for effective fixes:
o Failure mode effect analysis
o Hazard and critical control points (HAACP)
o Fault tree analysis (FTA)
* Case Studies:
o Laboratory out-of-specification incidents
o Manufacturing failures
o Manufacturing deviations
At the end of the course you will:
* Understand what an effective investigation is, and what it is not.
* Be able to implement tools that will allow the company to rapidly determine the root causes of deviations, problems and failures.
* Implement a sound and effective CAPA program.
* Know which tools to use in which situations, and how to sell management on effective corrective action and implementation.
* Be able to satisfy the regulatory authorities by performing effective and valid investigations.
* Use the tools taught in this course to incorporate cost-saving methodologies into your companyâ€™s failure investigations.
Who will benefit:
* Quality managers
* Production managers and top management interested in learning the value of good investigations, as well as how to enhance the QA investigative function as a valuable cost-savings and quality-improvement tool
* Auditors and government inspectors will find this course particularly useful in enhancing their inspections and capabilities.