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: Pharmaceutical Products, Pharmaceutical Chemistry, Good Manufacturing Practice (GMP)...

...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: Principles of GCP and GLP, Good Manufacturing Practice (GMP), Investigational Medicinal Products (IMPs)...

...of pharmaceutical materials. Importantly, it also includes the interpretation of analytical data including non-conforming results and stresses the importance... Learn about: Qualified Person (QP), 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: Regulatory Compliance, Report Writing, Decision Making...

...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: Products Retail, Quality Systems, Product Analysis...

...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 System, Goods importation, Goods exportation...

...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: Quality Systems, Goods importation, Quality Training...

...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 technologists, Quality Assurance, Good Manufacturing Practice (GMP)...

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

...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: Customer Inspections, Pharmaceutical manufacturing, Inspection Observations...

...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: Good Manufacturing Practice (GMP), Quality Testing, Quality control...

...It covers responsibilities and terminology (validation, verification, qualification), and looks at the requirements of equipment qualification... Learn about: Good Manufacturing Practice (GMP), Pharmaceutical manufacturing, Analytical method validation...

...the course moves through a series of case study scenarios and the consequent implications. Potential approaches to discharge management responsibilities are explored... Learn about: Regulatory Compliance, Pharmaceutical manufacturing, Quality Training...

...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: Sampling and testing techniques, Good Manufacturing Practice (GMP), Pharmaceutical manufacturing...

...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 auditing, GMP Documentation, Quality Management Systems...

...data trending and how to manage out of limit results. Additionally a review of risks associated with contamination sources, monitoring methods... Learn about: Pharmaceutical manufacturing, Manufacturing Process, Testing techniques...

...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: Good Manufacturing Practice (GMP), Risk Management, Quality Risk Management (QRM)...

...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: Pharmaceutical manufacturing, Internal/External Audits, ISO 9001...

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

...recalls continue to be related to packaging issues. This course closely examines the key stages of pharmaceutical packaging relevant to the... Learn about: Pharmaceutical manufacturing, Quality Systems, Printed Packaging Components...