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: Equipment qualification, Analytical method validation, Good Manufacturing Practice (GMP)...

...Management qualification or training. Anyone being prepared for promotion into a Project Management position. Experienced Project Managers looking for a refresher course...

...the management responsibilities for implementation and assessment of quality systems within an organisation. Most notably the changes specify Senior Management... Learn about: Quality management, Pharmaceutical manufacturing, Auditing documentation...

...working in sterile products manufacturing, QC (especially environmental monitoring personnel), QA personnel as well as support engineers. Learning Outcomes... Learn about: Pharmaceutical Industry, Regulatory Compliance, Sterile Products Manufacture...

...the course then covers process design, pitfalls and associated validation issues including sampling and testing. The course is designed so that the... Learn about: Pharmaceutical Plant Cleaning, Quality Training, Analytical method validation...

...Suitability This course is appropriate to a wide ranging audience, from QA and QC, through to production and clinical trials professionals. Learning Outcomes... Learn about: Regulatory Compliance, Quality Management Systems, Best Practice...

...use to anyone performing environmental monitoring and those involved in collating and interpreting the results obtained. Learning Outcomes At the end of the course you... Learn about: Identification of non-conformity, Manufacturing Process, Testing techniques...

...of Senior Management involvement and commitment in the design, implementation, maintenance and monitoring of the Pharmaceutical Quality System (PQS)... Learn about: Pharmaceutical manufacturing, Regulatory Compliance, Continuous Improvement...

...with supportive feedback provided throughout. The course is focused on pharmaceutical GMP and several subjects are explored in detail which helps build... Learn about: Pharmaceutical Industry, Good Manufacturing Practice (GMP), ISO 9001...

...risk ranking, cause-effect matrix and other related Risk Analysis techniques, such as process flow diagrams, ‘fishbone’, ‘brainstorming’ etc Appreciate... Learn about: Regulatory Guidelines, Good Manufacturing Practice (GMP), Quality Systems...

...Understand the regulatory framework for supplier audits Appreciate the commercial benefits of such audits Understand the ‘language’ of ISO 9001 and how... Learn about: Internal/External Audits, ISO 9001, Pharmaceutical Quality Group (PQG)...

...Influencing factors that create human errors Be aware of error situation traps Understand the difference between errors and violations Utilise basic tools... Learn about: Good Manufacturing Practice (GMP), Monitoring Tools, Learning Processes...

...Fully reviewing Good Distribution Practice (GDP) as required by Licence Holders, it provides an understanding of the key GDP Quality Systems required... Learn about: Good Manufacturing Practice (GMP), Responsible Person (RP), Quality Systems...

...In particular it examines the implications of the changes. Suitability The refresher course is aimed at RP’s and Deputy RP’s who have already undertaken... Learn about: Good Manufacturing Practice (GMP), Supply Chain Management, Quality Systems...

...organic solvents and impurities Process and cleaning validation The control of packaging materials for an... Learn about: Good Manufacturing Practice Standards, Supply Chain Management, Regulatory Compliance...

...and the drugs used to treat diseases associated with them: Pharmacology, Pharmacokinetics and Pharmacodynamics The autonomic nervous system... Learn about: Qualified Person (QP), Medicinal Chemistry, Pharmaceutical Products...

...statistical tools used in the Pharmaceutical Production (including manufacturing and control) environment in a time efficient manner. Learning Outcomes... Learn about: Quality Assurance, Probability and Risk, Acceptable Quality Levels (AQLs)...

...all product related complaints and recalls continue to be related to packaging issues. This course closely examines the key stages of pharmaceutical packaging... Learn about: Printed Packaging Components, Packaging Operations, Pharmaceutical manufacturing...

...viruses and toxins in pharmaceutical raw materials, intermediates, products and pharmaceutical production environments. In addition, the QP needs a... Learn about: Sterile and non-sterile products, Good Manufacturing Practice (GMP), Pharmaceutical Industry...

...of how these need to be managed. All activities are discussed and explained within the confines of current Good Quality Control Laboratory Practice... Learn about: Analytical method validation, Laboratory results analysis, Quality Control Laboratory Testing...