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, Enable effective auditing, Reporting on audits of suppliers...

...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: Industry insight, Pharmaceutical manufacturing, ISO 9001...

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

...is aimed at all personnel involved in any aspect of pharmaceutical packaging, including packing staff at all levels, packaging technologists... Learn about: Quality Training, Good Manufacturing Practice (GMP), Manufacturing Process...

...in the pharmaceutical industry where medical device regulations are applied - e.g. for inhalers, pre-filled syringes, infusion bags etc. Learning Outcomes... Learn about: Medical Device, Quality Training, Regulatory Compliance...

...monitoring programme appropriate for your operations Know how to interpret results and identify trends... Learn about: Testing techniques, Good Manufacturing Practice (GMP), Environmental Monitoring...

...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, Analytical method validation, Regulatory Compliance...

...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 Systems, Auditing documentation, Quality Training...

...production engineers, microbiologists, quality systems auditors and supplier auditors. Learning Outcomes At the end of the course you will: Appreciate... Learn about: Good Manufacturing Practice (GMP), Pharmaceutical Plant Cleaning, Analytical method validation...

...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 manufacturing, Good Manufacturing Practice (GMP), 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: Best Practice, Best Practice for Documentation, Quality Management Systems...

...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: Regulatory Compliance, Pharmaceutical manufacturing, Quality Systems...

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

...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: Pharmaceutical Quality Group (PQG), Pharmaceutical manufacturing, Internal/External Audits...

...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: Inspection Process, Regulatory Compliance, Pharmaceutical manufacturing...

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

...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: Goods exportation, Quality Systems, Quality Training...

...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, Internal Auditing, Confidence Training...

...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: Communication Skills, Decision Making, Auditing documentation...