Introduction to Validation (1-day)


The course introduces the concept of validation to the delegates. It covers responsibilities and terminology (validation versus qualification), and looks at the requirements of equipment qualification (IQ, OQ and PQ), process and cleaning validation, analytical method validation. The course also examines the documentation and project management aspects of validation studies.


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Managing Good Manufacturing Practice Compliance (1-day)


The revision of Chapter 1 (Quality Management) and Chapter 2 (Personnel) of Part I of the EU guide to GMP to bring it in line with ICH Q10 will mean an increasing regulatory focus on senior management responsibility for quality within an organisation.


This stimulating workshop is designed to make delegates think about where such responsibilities lie within their own organisation, and poses the important question of the ‘Cost of Quality’ versus the ‘Cost of Non-Compliance’.


Starting with a brief consideration of the key elements of GMP including any recent or proposed revisions, the course moves through a series of case study scenarios and the consequent implications. Potentially business critical situations are explored to identify root causes and effective remedial and preventive actions. This is particularly effective run as an in-house training course.


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Manufacturing Sterile Products (1-day)


This course provides an extensive introduction to the regulatory requirements governing pharmaceutical clean room operation, and details the aseptic filling and terminal sterilisation methods for producing sterile products. The delegates will gain an appreciation of the significance of sterile products to the patient, and understand why there is intensive regulatory interest worldwide in the control of sterile product manufacture.


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Pharmaceutical Lead Auditor (IRCA Ref A17129) (5-day)


The course is focused on ISO 9001 and the specific GMP standards that have been developed for the supply of packaging and excipient materials to the pharmaceutical industry. ISO 9001 is covered in detail and this will enable pharmaceutical auditors to converse in the language that is universally used by its suppliers. Frequent opportunities are provided to check knowledge acquired before the staged formal assessments and delegates are supported by regular constructive feedback.


Successful completion of this course provides the delegate with a qualification in auditing that is recognised by the International Register of Certified Auditors (IRCA) and the Pharmaceutical Quality Group (PQG). (This is a 5 day residential IRCA Accredited Course: Ref A17129, contact us separately for details on the course venue.)


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