Manufacturing training 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: Reporting on audits of suppliers, Basic manufacturing techniques, 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, Quality Training, Industry insight...

...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, Understand data, Goods exportation...

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

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

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

...and qualification requirements Be able to plan and document validation studies Understand the link to change management and ongoing lifecycle management... Learn about: Good Manufacturing Practice (GMP), Equipment qualification, 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: Good Manufacturing Practice (GMP), Auditing documentation, Pharmaceutical manufacturing...

...production engineers, microbiologists, quality systems auditors and supplier auditors. Learning Outcomes At the end of the course you will: Appreciate... Learn about: Sampling and testing techniques, Quality Training, Process 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: Opportunities for a QP, Pharmaceutical Industry, Becoming a Qualified Person...

...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: Archiving and retrieval, Pharmaceutical manufacturing, Quality auditing...

...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), Good Manufacturing Practice (GMP), Packaging Operations...

...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, Quality Testing...

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

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

...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 Observations, Quality Process, Inspection Process...

...Clinical Trials Regulation Cleaning Validation by Toxicity Risk Assessment, updated MHRA Guidance Data Integrity... Learn about: Quality Management Systems, 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: Quality Training, Quality Systems, 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: External auditing, Confidence Training, 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: Regulatory Compliance, Decision Making, Report Writing...