Courses in Reading

...The course also examines the documentation and project management aspects of validation studies. The need for effective change management and life-cycle... Learn about: Equipment qualification, Cleaning validation, Pharmaceutical manufacturing...

...and the potential reputation and cost consequences of non-compliance. Starting with a brief consideration of the key elements of the proposed revisions to the... Learn about: Quality Training, Auditing documentation, Quality management...

...Learning Outcomes At the end of the course you will: Understand the risks associated with sterile products Appreciate the requirements for contamination... Learn about: Clean room design, Aseptic filling and terminal sterilisation methods, Quality Training...

...This practical course covers basic issues in cleaning processes in pharmaceutical manufacturing, and the validation of those processes. After an introduction... Learn about: Quality Training, Pharmaceutical manufacturing, Sampling and testing techniques...

...of documentation Appreciate the importance of maintaining a comprehensive documentation system... Learn about: Quality auditing, Pharmaceutical manufacturing, Regulatory Compliance...

...trending and reporting of results is undertaken. Suitability This course is aimed at personnel in production and quality functions who wish to increase... Learn about: Good Manufacturing Practice (GMP), Testing techniques, Environmental Monitoring...

...which combines tutorials and exercises, enables Senior Managers to discover what their responsibilities are, how they can discharge them effectively... Learn about: Regulatory Compliance, Regulatory Inspections, Quality Training...

...This course provides an introduction to the requirements of internal auditing described in the international standard ISO 19011. Frequent opportunities... Learn about: ISO 9001, Quality auditing, Confidence Training...

...importance of product Critical Quality Attributes, Critical Process Parameters and Control Strategy in regard to science and risk based principles Appreciate how to use... Learn about: Regulatory Guidelines, Pharmaceutical manufacturing, Risk Management...

...IRCA (Ref A18215) and PQG Accredited Course. Suitability The course is suitable for people who have been doing some auditing already – perhaps internal... Learn about: Regulatory Compliance, Quality Management Systems, Pharmaceutical manufacturing...

...in the background to human errors and those seeking techniques to proactively target to design, implement and monitor human error programs within their businesses... Learn about: Learning Processes, Human Behaviour, Problem Solving...

...Appreciate the dangers and challenges posed by falsified products... Learn about: Good Distribution Practice (GDP) Guidlines, Good Manufacturing Practice (GMP), Licence Holder...

...and Deputy RP in the light of the extensive requirements included in the MHRA Orange/Green Guides in relation to current Good Distribution Practice (GDP)... Learn about: Quality Systems, Responsible Person (RP), Regulatory Compliance...

...organic solvents and impurities Process and cleaning validation The control of packaging materials for an... Learn about: Control of Packaging Materials, Process and Cleaning Validation, Pharmaceutical manufacturing...

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

...of data using mathematical and statistical techniques is a key element of controlling the quality of pharmaceutical products for human and veterinary... Learn about: Data analysis, Probability and Risk, Pharmaceutical manufacturing...

...the challenges and risks involved in packaging operations in the Pharmaceutical Industry. A significant percentage of all product related complaints... Learn about: Printed Packaging Components, Quality Systems, Regulatory Compliance...

...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, Qualified Person (QP), Pharmaceutical Industry...

...It also includes, sampling plans, physical and organoleptic testing, stability testing and the significance of degradation, contamination and adulteration... Learn about: Analytical Chemistry, Good Manufacturing Practice (GMP), Pharmaceutical manufacturing...

...end of the course you will know and understand: The key role the PQS plays in ensuring quality and compliance The key elements of a PQS The role of... Learn about: Pharmaceutical Quality System (PQS), Regulatory Compliance, Pharmaceutical manufacturing...