Manufacturing courses Reading

...This course will provide the basic knowledge base and skills to enable effective auditing and reporting on audits of suppliers of active pharmaceutical ingredients (APIs)... Learn about: Basic manufacturing techniques, Reporting on audits of suppliers, Enable effective auditing...

...consideration of the context of the organisation. Learning Outcomes By the end of the day, you will: Understand the new ‘HLS’ structure of ISO 9001:2015... Learn about: ISO 9001, Good Manufacturing Practice (GMP) standards, Pharmaceutical manufacturing...

...training and facilities. This informative course introduces the EU Guide to GMP and considers its implementation in the modern pharmaceutical regulatory environment... Learn about: Manufacturing Production, Pharmaceutical manufacturing, Manufacturing Technology...

...is aimed at all personnel involved in any aspect of pharmaceutical packaging, including packing staff at all levels, packaging technologists... Learn about: Packaging Operations, Pharmaceutical manufacturing, Packaging technologists...

...in the pharmaceutical industry where medical device regulations are applied - e.g. for inhalers, pre-filled syringes, infusion bags etc. Learning Outcomes... Learn about: Pharmaceutical manufacturing, Medical Device, Manufacturing Process...

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

...and qualification requirements Be able to plan and document validation studies Understand the link to change management and ongoing lifecycle management... Learn about: Equipment qualification, Regulatory Compliance, Analytical method validation...

...elements of the proposed revisions to the GMPs, the course moves through a series of case study scenarios and the consequent implications. Potential approaches... Learn about: Quality management, Regulatory Compliance, Management Operations...

...production engineers, microbiologists, quality systems auditors and supplier auditors. Learning Outcomes At the end of the course you will: Appreciate... Learn about: Process validation, Pharmaceutical manufacturing, Sampling and testing techniques...

...with an avid interest in QP training as well as those who are interested in finding out more about what it takes to become a Qualified Person... Learn about: Pharmaceutical Industry, Becoming a Qualified Person, Training Programme...

...GMP documents and documentation systems understand the regulatory requirements and adopts best practice. As such this course provides a step by step explanation... Learn about: Quality Management Systems, Archiving and retrieval, Best Practice for Documentation...

...and engineers supporting packing operations. Learning Outcomes By the end of the course you will: Have a good understanding of the various packaging materials... Learn about: Qualified Person (QP), Regulatory Compliance, Good Manufacturing Practice (GMP)...

...control and how this links to clean room design Understand the methods for terminal sterilisation and processes involved in aseptic product manufacture... Learn about: Pharmaceutical Industry, Clean room design, Sterile Products Manufacture...

...Learning Outcomes At the end of the course you will: Understand the regulatory drivers for QRM, with particular emphasis on European and US requirements... Learn about: Quality Systems, Quality Training, Risk analysis techniques...

...the delegate with a qualification in auditing that is recognised by the International Register of Certified Auditors (IRCA) and the Pharmaceutical Quality Group (PQG)... Learn about: Quality Management Systems, Pharmaceutical manufacturing, Good Manufacturing Practice (GMP) standards...

...Suitability The course is suitable for people who are responsible for preparing external inspections and those requiring knowledge and understanding of the inspection process... Learn about: Regulatory Compliance, Customer Inspections, Pharmaceutical manufacturing...

...Clinical Trials Regulation Cleaning Validation by Toxicity Risk Assessment, updated MHRA Guidance Data Integrity... Learn about: Pharmaceutical manufacturing, GMP update, Quality Management Systems...

...way confidently around the rules and guidelines of GMP Be able to find your way confidently around the UK ‘Orange Guide’, (which incorporates the EU Guide to GMP)... Learn about: Quality Systems, Quality Training, Goods exportation...

...of internal audits Initiate an audit Create a structured audit programme Conduct an opening and a closing meeting Create a check list of questions to... Learn about: ISO 19011, External auditing, ISO 9001...

...create a check list of questions to ask • Be able to identify non conformities against ICH Q7 and regulatory expectations • Be able to identify product... Learn about: Auditing documentation, Regulatory Compliance, Decision Making...