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: Good Manufacturing Practice (GMP), Quality Management Systems, Pharmaceutical manufacturing...

...with contamination sources, monitoring methods, trending and reporting of results is undertaken. Course Overview The course addresses environmental monitoring... Learn about: Testing results interpretation, Good Manufacturing Practice (GMP), Manufacturing Process...

...what constitutes ‘visually clean’ Be aware of the issues surrounding sampling and testing techniques Appreciate the importance of analytical method validation... Learn about: Pharmaceutical manufacturing, Quality Training, Process validation...

...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 control, Microbiological analysis, Good Manufacturing Practice (GMP)...

... packaging relevant to the QP, from component manufacture and supply to final product release including QP certification... Learn about: Regulatory Compliance, Packaging Operations, Qualified Person (QP)...

... Substance Development) along with its practical application in development, manufacturing, engineering and validation. The course will be aligned to the latest science and risk based principles and regulatory guidances in the EU and... Learn about: Risk Management, Quality Training, 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: Regulatory Compliance, Good Manufacturing Practice (GMP), Qualified Person (QP)...

...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: Supply Chain Management, Pharmaceutical manufacturing, Process and Cleaning Validation...

... one of the most important functions in the manufacturing environment. Many of the GMP regulations and guidances apply to control laboratories but in particular Chapter 6 (QC and Good Control Laboratory Practice) of the EU Guide to GMP. The course also covers the role of documentation, pharmacopoeias, laboratory reference... Learn about: Quality Training, Pharmaceutical manufacturing, Laboratory Practice...

...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: Packaging technologists, Quality Training, Packaging Operations...

...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: Goods exportation, Pharmaceutical laboratory administration, Understand data...

... 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: Good Manufacturing Practice (GMP) standards, 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: Quality Testing, Medical Device, Quality Training...

...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: Quality Training, Good Manufacturing Practice (GMP), Regulatory Inspections...

...external context Be aware of the transitional timings for the introduction of ISO9001:... Learn about: Pharmaceutical manufacturing, Industry insight, 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 manufacturing, Good Manufacturing Practice (GMP), Pharmacokinetics and Pharmacodynamics...

...for the QP Be aware of the requirements and expectations for QP Sponsors Understand a QP Assessor’s view... Learn about: Assessment process, Pharmaceutical manufacturing, Becoming a Qualified Person...

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

...Influencing factors that create human errors Be aware of error situation traps Understand the difference between errors and violations Utilise basic tools... Learn about: Learning Processes, Good Manufacturing Practice (GMP), 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: Regulatory Compliance, Management Operations, Quality Training...