Industry and Science Training Berkshire

...Course Overview Qualified Persons cannot fulfil their role in a responsible way unless they understand the actions and uses of the medicinal products manufactured... Learn about: Pharmacokinetics and Pharmacodynamics, Good Manufacturing Practice (GMP), Medicinal Chemistry...

...the opportunity to learn about the principles of Good Clinical and Good Laboratory Practice, and how these relate to GMP for IMPs. Course Overview... Learn about: Investigational Medicinal Products (IMPs), Good Manufacturing Practice (GMP), Qualified Person (QP)...

...of pharmaceutical materials. Importantly, it also includes the interpretation of analytical data including non-conforming results and stresses the importance... Learn about: Laboratory results analysis, Good Manufacturing Practice (GMP), Stability Testing...

...SUITABILITY The course is suitable for people who have had some auditor training and experience in conducting audits. It is specifically designed for those... Learn about: Report Writing, Communication Skills, Regulatory Compliance...

...as required by Directive 2001/83/EC, Directive 2004/27/EC, EU Guidelines on Good Distribution of Medicinal Products for Human Use 2003/C343/01 and... Learn about: Production Quality, Products Retail, Product marketing...

...This course is suitable for all pharmaceutical professionals, including newcomers to the industry, who wish to gain a solid knowledge and understanding... Learn about: Manufacturing Production, Pharmaceutical Research, Manufacturing Technology...

...over three intensive days. It covers the regulations and guidelines associated with GMPs and the expectations of the MHRA and FDA. Topics examined include incoming materials... Learn about: Goods importation, Quality Systems, Goods exportation...

...and discusses how these can be removed or managed. Course Overview The packing process is a complex series of operations, often performed at high speeds... Learn about: Packaging Operations, Packaging technologists, Manufacturing Process...

...Course Overview This interactive Good Manufacturing Practice (GMP) training course covers the requirements of the Medical Device Regulatory Standard... Learn about: Medical Device, Quality Training, Pharmaceutical manufacturing...

...It is also suitable for anyone who is responsible for responding to inspection findings/deficiencies. Learning Outcomes At the end of the course you... Learn about: Quality Process, Regulatory Compliance, Customer Inspections...

...it will review the impact of microbiology on many aspects of pharmaceutical manufacture and control. This course looks at the nature of micro-organisms... Learn about: Quality Testing, Quality control, Good Manufacturing Practice (GMP)...

...It covers responsibilities and terminology (validation, verification, qualification), and looks at the requirements of equipment qualification... Learn about: Cleaning validation, Good Manufacturing Practice (GMP), Regulatory Compliance...

...the course moves through a series of case study scenarios and the consequent implications. Potential approaches to discharge management responsibilities are explored... Learn about: Quality Systems, Good Manufacturing Practice (GMP), Quality management...

...1-day course covers basic issues in cleaning processes in pharmaceutical manufacturing, and the validation of those processes. After an introduction to the overall objectives... Learn about: Good Manufacturing Practice (GMP), Analytical method validation, Pharmaceutical Plant Cleaning...

...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... Learn about: Quality Management Systems, Archiving and retrieval, Pharmaceutical manufacturing...

...data trending and how to manage out of limit results. Additionally a review of risks associated with contamination sources, monitoring methods... Learn about: Testing results interpretation, Good Manufacturing Practice (GMP), Environmental Monitoring...

...of the principles of Quality Risk Management (QRM) and its practical application. The course is focused on ICH Q9 (QRM) and its support to ICH... Learn about: Risk Management, Quality Risk Management (QRM), Quality Systems...

...second and third-party audits of quality management systems, against ISO 9001 and the specific GMP standards that have been developed for the supply of packaging... Learn about: Internal/External Audits, Regulatory Compliance, Quality Management Systems...

...to the Qualified Person and the descriptive statistics used in everyday data analysis of the Pharmaceutical Quality System. Course Overview Evaluation... Learn about: Pharmaceutical Quality System, Acceptable Quality Levels (AQLs), Probability and Risk...

...recalls continue to be related to packaging issues. This course closely examines the key stages of pharmaceutical packaging relevant to the... Learn about: Packaging Operations, Printed Packaging Components, Qualified Person (QP)...