Courses in Reading

...Course Overview This course provides an introduction to the requirements of systematic failure investigation (FI) and corrective and preventive action (CAPA)... Learn about: Document Management, Company policy and procedure, Identify probable root cause...

...It offers a practical explanation of the guidelines for those who are active in the field of setting up and implementing GDP, as well as those involved... Learn about: Products Retail, Product marketing, Quality Training...

...to EU GMP and how it is applied in the UK as the Orange Guide Understand the expectations of current good manufacturing practices, and how these can... Learn about: Goods importation, Manufacturing Technology, Pharmaceutical manufacturing...

...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, Quality Training, Goods exportation...

...Understand claim substantiation and product labelling Know how compliance can be enforced The course includes a range of exercises and practical activities... Learn about: Cosmetics Regulations, Product Information File requirements, Cosmetic ingredients...

...engineers, auditors, QC and QA. Learning Outcomes At the end of the course you will: Have an understanding of the key GMP requirements for pharmaceutical... Learn about: Packaging technologists, Manufacturing Process, Quality Assurance...

...13485 and the regulatory framework and documentation required to market a medical device. Those attending will get an understanding of the requirements... Learn about: Quality Process, Quality Training, Regulatory Compliance...

...laid out in GMP both in the European and USA regulations and guidance documents. The pharmaceutical quality control laboratory serves one of the most important... Learn about: Quality Training, Pharmaceutical manufacturing, Laboratory Practice...

...for external inspections by customers and regulators, manage an external inspection and respond to inspection observations including addressing any deficiencies raised... Learn about: Regulatory Compliance, Inspection Process, Quality Process...

...This course is designed specifically as an introduction to the important topic of pharmaceutical microbiology, it will review the impact of microbiology... Learn about: Quality Testing, Microbiological analysis, Quality control...

...management will be discussed. Course Overview The course provides an overview of the concept of validation as described in Annex 15 to Eudralex Volume... Learn about: Good Manufacturing Practice (GMP), Pharmaceutical manufacturing, Analytical method validation...

...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: Management Operations, Quality Training, Quality management...

...and understand why there is intensive regulatory interest worldwide in the control of sterile product manufacture. Suitability This course will provide... Learn about: Quality Training, Aseptic filling and terminal sterilisation methods, Regulatory Compliance...

...the course then covers process design, pitfalls and associated validation issues including sampling and testing. The course is designed so that the... Learn about: Good Manufacturing Practice (GMP), Process validation, Analytical method validation...

...of what to do when managing GMP documentation and documentation systems. Course Overview Documentation is the cornerstone of any company’s quality management... Learn about: Good Manufacturing Practice (GMP), Pharmaceutical manufacturing, Best Practice for Documentation...

...monitoring programme appropriate for your operations Know how to interpret results and identify trends... Learn about: Good Manufacturing Practice (GMP), Manufacturing Process, Identification of non-conformity...

...and develop an action plan to facilitate delivery in their organisations. Course Overview Recent changes to the EU Guide to GMP emphasise theimportance... Learn about: Regulatory Inspections, Regulatory Compliance, Key Performance Indicators (KPIs)...

...It is also suitable for those who wish to refresh their skills. Learning Outcomes By the end of the course you will be able to: Understand the benefits... Learn about: Internal Auditing, Pharmaceutical Industry, Quality auditing...

...and expectations Understand how ICH Q9 underpins ICH Q8, Q10 and Q11 for activities in development, manufacturing, engineering and process validation Understand... Learn about: Risk Management, Risk analysis techniques, Quality Risk Management (QRM)...

...This 5 day residential course is focused on providing you with the knowledge and skills required to perform first, second and third-party audits of quality management systems... Learn about: Internal/External Audits, Quality Training, Regulatory Compliance...