This 5 day fully residential course provides the most comprehensive certification for Lead Auditors to the supply chain in the Pharmaceutical industry. Fully accredited by IRCA and PQG, this is a highly customised Lead Auditor training course that provides the delegate with a qualification in auditing that is recognised by the International Register of Certified Auditors(IRCA) to ISO9001 Quality Management Systems and The Pharmaceutical Quality Group (PQG) PS9000 Pharmaceutical Supplier Standards.
This course is founded on the audit principles defined in ISO19011:2018, and supporting ISO standards, and provides an excellent structure on which to introduce, develop or monitor both internal and external audit processes. PR330 incorporates the principles of performing 1st, 2nd and 3rd party audits as a Lead Auditor to the supply chain of pharmaceutical manufacture. This course is intended for individuals to acquire the knowledge and skills to lead audits of suppliers utilising ISO9001, PS9000, ISO9001, EXCiPACT, ISO15378, and IPEC. The regulatory background for medicinal products and an overview of the standard content is discussed. Exercises are also included for ICHQ7 for active pharmaceutical ingredients however this does not form part of the examination process detailed below.
This course is founded on the audit principles defined in ISO19011:2018, and supporting ISO standards, and provides an excellent structure on which to introduce, develop or monitor both internal and external audit processes. PR330 incorporates the principles of performing 1st, 2nd and 3rd party audits as a Lead Auditor to the supply chain of pharmaceutical manufacture. This course is intended for individuals to acquire the knowledge and skills to lead audits of suppliers utilising ISO9001, PS9000, ISO9001, EXCiPACT, ISO15378, and IPEC. The regulatory background for medicinal products and an overview of the standard content is discussed. Exercises are also included for ICHQ7 for active pharmaceutical ingredients however this does not form part of the examination process detailed below.
