Documentation (1-day)
Documentation is the cornerstone of any company’s quality management system and is an essential GMP requirement. It is critical that anyone dealing with GMP documents and documentation systems understand the regulatory requirements and adopts best practice.
As such this course provides a step by step explanation of what to do when managing GMP documentation and documentation systems.
More Environmental Monitoring (1-day)
The course addresses environmental monitoring for the manufacturing of both sterile and non-sterile products. It looks at the legislation and guidance available, techniques employed to monitor pharmaceutical environments, data trending and how to manage out of limit results. Additionally a review of risks associated with contamination sources, monitoring methods, trending and reporting of results is undertaken.
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Failure Investigation and CAPA (2-day)
This course provides an introduction to the requirements of systematic failure investigation (FI) and corrective and preventive action (CAPA) practices as described in ICH Q9 and made a regulatory requirement in Europe by Annex 20 of the Guide to GMP, and in the USA by the Federal Register/FDA Guidance for Industry.
The course is focused on company responsibilities within a quality risk management system, and several investigational tools are explored to help build up knowledge of techniques that might be used by a company to provide a structure for systematic investigation of failure.
Numerous exercises are run throughout the course to provide realistic examples of events requiring investigation, providing an opportunity to practice investigation and writing up of corrective actions within teams. Examples of the use of, and outputs from, more complex techniques are presented.
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Evaluation of Contract Distributors (1-day)
This workshop based course covers responsibilities of the Qualified and Responsible Persons (QP and RP) within the supply chain. It also looks at extended supply chains, shipping conditions and counterfeits and the current regulatory climate and reasons for concern, recognising that two current MHRA hot topics include the supply chain weak links and the risks from illegal entry of counterfeit products. This RSSL certificated course also offers an assessment of knowledge for CPD purposes.
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“Loads of useful and practical tips, interesting examples, very interactive and good atmosphere to learn! Audience specific orientated.”
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