Engineering and Manufacturing Training Berkshire

...non conformities against ICH Q7 and regulatory expectations Identify product specific requirements Have knowledge of the basic manufacturing techniques... Learn about: Enable effective auditing, Basic manufacturing techniques, Reporting on audits of suppliers...

...we will be running a CPD day to look at what has changed recently in ISO 9001. This is a good opportunity for auditors, quality professionals and senior... Learn about: Quality Training, ISO 9001, Key changes...

...in the essentials of pharmaceutical GMP. Learning Outcomes By the end of the course you will be able to: Find your way confidently around the EU Guide... Learn about: Goods importation, Pharmaceutical manufacturing, Manufacturing Technology...

...and against tight deadlines. Despite the increased use of many on line detection/rejection systems, the majority of pharmaceutical quality complaints... Learn about: Pharmaceutical manufacturing, Packaging technologists, Manufacturing Process...

...13485 and the regulatory framework and documentation required to market a medical device. Those attending will get an understanding of the requirements... Learn about: Regulatory Compliance, Pharmaceutical manufacturing, Medical Device...

...trending and reporting of results is undertaken. Suitability This course is aimed at personnel in production and quality functions who wish to increase... Learn about: Good Manufacturing Practice (GMP), Environmental Monitoring, Testing techniques...

...including control of suppliers of APIs, excipients and packaging materials. Other sessions examine manufacturing, packaging, premises, equipment... Learn about: Goods importation, Quality Training, Quality Systems...

...OQ and PQ), process and cleaning validation, analytical method validation. The course also examines the documentation and project management aspects of validation studies... Learn about: Equipment qualification, Cleaning validation, Pharmaceutical manufacturing...

...Course Overview The revision of Chapter 1 (Quality Management) and Chapter 2 (Personnel) of Part I of the EU guide to GMP to incorporate ICH Q10 brings... Learn about: Pharmaceutical manufacturing, Management Operations, Good Manufacturing Practice (GMP)...

...the course then covers process design, pitfalls and associated validation issues including sampling and testing. The course is designed so that the... Learn about: Analytical method validation, Pharmaceutical manufacturing, Sampling and testing techniques...

...a mentor and the support they provide throughout the training process. You will have the opportunity to meet fellow industry professionals and discuss... Learn about: Requirements and expectations for QP Sponsors, Assessment process, Becoming a Qualified Person...

...Suitability This course is appropriate to a wide ranging audience, from QA and QC, through to production and clinical trials professionals. Learning Outcomes... Learn about: Best Practice for Documentation, Pharmaceutical manufacturing, Good Manufacturing Practice (GMP)...

...from component manufacture and supply to final product release including QP certification. Suitability This course has been designed specifically... Learn about: Packaging materials, Good Manufacturing Practice (GMP), Printed Packaging Components...

...and understand why there is intensive regulatory interest worldwide in the control of sterile product manufacture. Suitability This course will provide... Learn about: Quality Training, Sterile Products Manufacture, Pharmaceutical Clean Room Operation...

...(Pharmaceutical Development), Q10 (Quality Systems) and Q11 (Drug Substance Development) along with its practical application in development... Learn about: Risk Management, Quality Risk Management (QRM), Quality Training...

...excipient and Active Pharmaceutical Ingredient (API) materials to the pharmaceutical industry. ISO 9001 is covered in detail and this will enable pharmaceutical... Learn about: Pharmaceutical manufacturing, Regulatory Compliance, Quality Training...

...Understand how to prepare for inspection Be familiar with key roles, and responsibilities Understand how to host an external inspection Understand... Learn about: Inspection Observations, Pharmaceutical manufacturing, Regulatory Compliance...

...Management Systems and Regulatory professionals. Legislation and Guidelines relevant to the manufacture of medicinal products in the European Union... Learn about: Legislation and guidelines update, GMP update, Pharmaceutical manufacturing...

...with supportive feedback provided throughout. The course is focused on pharmaceutical GMP and several subjects are explored in detail which helps build... Learn about: External auditing, Internal Auditing, Pharmaceutical Industry...

...responsible for assessing the content and findings of API audit reports as part of license applications and variations, as well as those Qualified Persons... Learn about: Regulatory Compliance, Decision Making, Auditing documentation...