Pharmaceutical Quality Control Risk Managment & Operational Excellence
May 2008 saw the inaugural Medical HACCP Alliance Pharmaceutical HACCP training programme take place in Williamsburg VA USA. It was well attended by FDA, industry, academia and consultants.
Eoin Barry of ARV Excellence Ltd. was part of the training team. In addition to the curriculum he presented insights on the integration of Medical HACCP and MDLeanSigma, the ARV Excellence life science Six Sigma programme.
Other trainers included Dr. George Flick, Dr. Kaiser Aziz, Captain Joseph Sayler, Mr. Stan Masterangelo. Another highlight of the conference was when Dr. Steven Reich, risk management principle at Wyeth presented a case study on the implementation of HACCP in pharmaceutical manufacturing and how it was successfully used in a submission to the FDA.
HACCP is Hazard Analysis Critical Control Points. It is a well proven system of managing risk in manufacturing. Modern HACCP has its roots in NASA and their approach to astronaut food manufacture. The system is very complete and it links the output of hazard analysis tools such as FMEA with preventative action, critical control point monitoring, process verification, validation and audit. It blends seamlessly with operational excellence approaches and is an excellence vehicle for the implementation of the quality system regulations. HACCP is recommended by the WHO (World health organisation) and the international harmonisation guideline ICH Q9, quality control risk management. It is also referenced in ISO 14971.
Autumn 2008 will see the Pharmaceutical HACCP risk management programme come to Ireland. For more information contact email@example.com
© 2008 ARV Excellence Ltd.
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