QRM Certification Training to Pharma-Bio Serv Resources
Risk Management Tools and Quality Management System Standards have been used to provide guidance for companies implementing Quality Systems, with the ultimate goal of improving quality, increasing productivity and making companies more competitive.
US FDA CDRH adopted the Quality Systems Regulations, harmonized with the Medical Device CFR regulations and with ISO Standards. In 2006, FDA CDER, CBER, CVM and ORA issued The Quality Systems Approach to Pharmaceutical CGMP Regulations, establishing that the implementation of effective Quality and Risk Management Systems will allow firms to fully comply with GMP standards. The issuance of ICH Q8, Q9, Q10 as well as the ASTM E2500 standard and most recently GAMP 5 demonstrate a historic alignment of the regulatory agencies around the globe as well as the professional and international standards organizations to a common language: protect consumers based upon assessment of risks while relieving the excessive and non value added activities that increase business costs without a scientific rationale to justify them. Although most of them are still guidelines, we anticipate that regulatory agencies will look after the scientifically sound risk management applications for cGMP enforcement.
Pharma-Bio Serv recognizes the impact of this new regulatory approach and understands the value it brings to our clients if scientifically deployed. We have experienced how the new approach can be successfully applied under a strict compliant status while shortening project schedules and making much more business sense. To that effect, we decided to invest in an internal certification program to have our scientists, specialists and consultants acquire the required knowledge, practice and application of risk management tools. Our first module was held on September 6th and we expect full delivery of a total of six (6) modules by first quarter, 2009. Congratulations to the group that joined the team of QRM leaders of the industry!
