Pharmaceutical manufacturing courses Berkshire

...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: Archiving and retrieval, Good Manufacturing Practice (GMP), Regulatory Compliance...

...with contamination sources, monitoring methods, trending and reporting of results is undertaken. Course Overview The course addresses environmental monitoring... Learn about: Environmental Monitoring, Testing techniques, Pharmaceutical manufacturing...

...what constitutes ‘visually clean’ Be aware of the issues surrounding sampling and testing techniques Appreciate the importance of analytical method validation... Learn about: Analytical method validation, Process validation, Good Manufacturing Practice (GMP)...

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

...The QP needs to fully understand the challenges and risks involved in packaging operations in the Pharmaceutical Industry. A significant percentage of all product related complaints and recalls continue to be related to packaging issues. This course closely examines the key stages of pharmaceutical... Learn about: Packaging Operations, Regulatory Compliance, Quality Systems...

...Successful completion of this one day course provides the delegate with understanding 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 Q8 (Pharmaceutical Development), Q10 (Quality Systems) and Q11 (Drug... Learn about: Quality Training, Pharmaceutical manufacturing, Risk analysis techniques...

...legal and operational responsibilities. This course provides a comprehensive overview of the requirements of the UK Study Guide. Scenarios and exercises... Learn about: Pharmaceutical manufacturing, Qualified Person (QP), Quality Training...

...Revisions to EU GMPs mean that the responsibilities of the Qualified Person regarding Active Pharmaceuticals are wider than ever. These include formally certifying that each Active Pharmaceutical Ingredient (API) is manufactured to GMP, knowledge of the API supply chain and complying... Learn about: Good Manufacturing Practice Standards, Supply Chain Management, Manufacturing API's...

...This course is an adaptation of our standard 1-day GMP course, designed specifically for laboratory staff who have unique, additional requirements laid out in GMP both in the European and USA regulations and guidance documents. The pharmaceutical quality control laboratory serves... Learn about: Quality Training, Laboratory Practice, Pharmaceutical manufacturing...

...The packing process is a complex series of operations, often performed at high speeds and against tight deadlines. Despite the increased use of many on line detection/rejection systems, the majority of pharmaceutical quality complaints and recalls are packaging related. This course gives a detailed... Learn about: Quality Training, Packaging technologists, Quality Assurance...

...This interactive course examines why we have Good Manufacturing Practice (GMP), its legal status and the key GMP issues surrounding pharmaceutical manufacture such as documentation, training and facilities. This informative course introduces the EU Guide to GMP and considers its implementation... Learn about: Understand data, Manufacturing Technology, Manufacturing Production...

... chain for their pharmaceutical product from Active Pharmaceutical Ingredients, through excipient sourcing, manufacturing, packaging materials, and all distribution steps through to reaching the final customer/user. Frequently asked questions include: Which department should be responsible for the supply... Learn about: Pharmaceutical manufacturing, Regulatory Compliance, Supply Chain mapping...

...This interactive Good Manufacturing Practice (GMP) training course covers the requirements of the Medical Device Regulatory Standard ISO 13485 and... Learn about: Regulatory Compliance, Pharmaceutical manufacturing, Medical Device...

...Recent changes to the EU Guide to GMP emphasise the importance of Senior Management involvement and commitment in the design, implementation, maintenance and monitoring of the Pharmaceutical Quality System (PQS). This is the first time that European guidance explicitly articulates the wide-ranging... Learn about: Pharmaceutical manufacturing, Quality Training, Continuous Improvement...

...external context Be aware of the transitional timings for the introduction of ISO9001:... Learn about: Risk Management, Pharmaceutical manufacturing, Good Manufacturing Practice (GMP) standards...

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

...for the QP Be aware of the requirements and expectations for QP Sponsors Understand a QP Assessor’s view... Learn about: Assessment process, Requirements and expectations for QP Sponsors, Good Manufacturing Practice (GMP)...

...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, Regulatory Compliance, Pharmaceutical manufacturing...

...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, Problem Solving...

...cost to a company of non-compliance Understand the applications of risk management reviews to drive actions to achieve andmaintain GMP compliance Appreciate... Learn about: Quality Systems, Auditing documentation, Quality Training...