Training in Reading

...OQ and PQ), process and cleaning validation, analytical method validation. The course also examines the documentation and project management aspects of validation studies... Learn about: Good Manufacturing Practice (GMP), Regulatory Compliance, Cleaning validation...

...To demonstrate how to define the Key Phases of the Project Life Cycle. To illustrate the importance of creating an accurate Project Specification...

...their organisation including those at senior management level. Learning Outcomes By the end of the course you will: Understand the potential impact... Learn about: Good Manufacturing Practice (GMP), Auditing documentation, Quality Systems...

...valuable underpinning knowledge to all personnel working for companies responsible for the manufacture of sterile products. It will be of benefit to those... Learn about: Aseptic filling and terminal sterilisation methods, Sterile Products Manufacture, Pharmaceutical Clean Room Operation...

...Numerous practical exercises are run throughout, providing clear demonstrations of techniques to employ - and pitfalls to avoid! Course Overview This practical... Learn about: Quality Training, Good Manufacturing Practice (GMP), Process validation...

...of documentation Appreciate the importance of maintaining a comprehensive documentation system... Learn about: Archiving and retrieval, Regulatory Compliance, Best Practice...

...The course addresses environmental monitoring for the manufacturing of both sterile and non-sterile products. It looks at the legislation and guidance available... Learn about: Testing results interpretation, Pharmaceutical manufacturing, Manufacturing Process...

...in an effective PQS The importance of Key Performance Indicators (KPIs) and management reviews ‘Deming Cycle’ and continuous improvement of the PQS... Learn about: Key Performance Indicators (KPIs), Pharmaceutical Quality System (PQS), Good Manufacturing Practice (GMP)...

...up knowledge and confidence in GMP. The range of other standards appropriate to external auditing (e.g. GDP, ISO 9001) are described briefly but not explored in depth... Learn about: External auditing, Internal Auditing, ISO 9001...

...how to set up and run a risk management exercise, including team selection, risk assessment, analysis, control, review and communication Recognise... Learn about: Good Manufacturing Practice (GMP), Quality Training, Regulatory Guidelines...

...auditors to converse in the language that is universally used by its suppliers. On successful completion of this course, delegates may apply for professional... Learn about: Quality Training, Pharmaceutical Quality Group (PQG), Pharmaceutical manufacturing...

...This course is designed to provide an understanding of why we create errors, how the human brain operates and learns and tools, techniques and approaches... Learn about: Monitoring Tools, Human Behaviour, Problem Solving...

...operate and fully meet regulatory requirements. The course is designed to cover the key elements of the new Responsible Person Gold Standard. Course Overview... Learn about: Quality Training, Deputy Responsible Person, Supply Chain Management...

...of your responsibilities and accountabilities as an RP and or Quality Champion, with a clear focus on the new legal and compliance aspects Have a comprehensive... Learn about: Supply Chain Management, Good Manufacturing Practice (GMP), Quality Systems...

...These include formally certifying that each Active Pharmaceutical Ingredient (API) is manufactured to GMP, knowledge of the API supply chain and complying... Learn about: Process and Cleaning Validation, Active Pharmaceutical Ingredient (API), Manufacturing API's...

...those they are asked to certify. The course provides further understanding of product ‘fit for its intended use’. This three day module takes major therapeutic... Learn about: Pharmacokinetics and Pharmacodynamics, Qualified Person (QP), Pharmaceutical Chemistry...

...The Qualified Person must understand the derivation and application of the data with which they will be presented. This course focuses on the practical... Learn about: Pharmaceutical manufacturing, Data analysis, Probability and Risk...

...their characteristics and how they are manufactured Appreciate the need to understand and work with suppliers of all packaging components; especially printed... Learn about: Regulatory Compliance, Printed Packaging Components, Pharmaceutical manufacturing...

...the QP needs a good understanding of the microbiological control of pharmaceutical products, production environments and people. This course will cover... Learn about: Pharmaceutical production operations, Testing techniques, Microbiology of water...

...It also includes, sampling plans, physical and organoleptic testing, stability testing and the significance of degradation, contamination and adulteration... Learn about: Testing techniques, Quality Control Laboratory Testing, Analytical method validation...