Reading scientific Services Limited courses

...This workshop has been designed to pull together the information in a way that provides participants with a good overview of the quality and regulatory... Learn about: Quality Systems, Contamination risks, Qualified Person (QP)...

...managers to refresh their knowledge and gain an appreciation of the key changes in ISO 9001:2015 vs 2008. Whilst all ISO standards are revised regularly... Learn about: Pharmaceutical manufacturing, Risk Management, Quality Training...

...pharmaceutical ingredients (APIs). The course is focused on the requirements of ICH Q7 and EU GMP Part II and the expectations of regulatory bodies both in the USA and Europe... Learn about: Decision Making, Communication Skills, Regulatory Compliance...

...This course is aimed at reviewing the key relevant standards that one might expect to audit against, providing a strong foundation for the application of auditing skills... Learn about: Quality management, IT Auditing, Quality Training...

...appropriate data governance process in relation to manual (paper) and electronic data. Suitablity This course is suitable for people with the responsibility... Learn about: Process Control, Design and qualification, Archiving and retrieval...

...by the tutor and comments on use of English will be made as appropriate. Suitability This course is designed for people who write reports, proposals and business cases... Learn about: Report editing, Target markets, Writing clearlly...

...for effective implementation of actions Appreciate the importance of documenting the Identify company policy and procedure required to meet regulatory requirements... Learn about: Company policy and procedure, CAPA system, Document processing...

...who carry out any GDP activities on behalf of licence holders. Responsible Persons’s (RP), deputy RP’s, quality managers, auditors, and regulatory/compliance... Learn about: Production Quality, Product Analysis, Product marketing...

...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... Learn about: Understand data, Goods exportation, Pharmaceutical Research...

...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 importation...

...An in-depth, interactive course which gives delegates a full overview and understanding of the cosmetics regulations in the EU, and what you need to know to market a product... Learn about: Claim substantiation and product labelling, Cosmetics Regulations, Cosmetic ingredients...

...packing Fully appreciate the inter related elements required to successfully run a packing operation in the pharmaceutical industry Understand the risks... Learn about: Good Manufacturing Practice (GMP), Pharmaceutical manufacturing, Quality Training...

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

...calibration, calculations and results. The final session of the course brings all this together by a session on preparing for regulatory inspection. Course... Learn about: Laboratory Practice, Quality Training, Pharmaceutical manufacturing...

...Understand how to prepare for inspection Be familiar with key roles, and responsibilities Understand how to host an external inspection Understand... Learn about: Inspection Process, Inspection Observations, Quality Process...

...it will review the impact of microbiology on many aspects of pharmaceutical manufacture and control. This course looks at the nature of micro-organisms... Learn about: Quality control, Pharmaceutical manufacturing, Quality Testing...

...The course provides an overview of the concept of validation as described in Annex 15 to Eudralex Volume 4. It covers responsibilities and terminology (validation... Learn about: Regulatory Compliance, Analytical method validation, Good Manufacturing Practice (GMP)...

...their organisation including those at senior management level. Learning Outcomes By the end of the course you will: Understand the potential impact... Learn about: Auditing documentation, Quality management, Regulatory Compliance...

...an extensive introduction to the regulatory requirements governing pharmaceutical clean room operation, and details the aseptic filling and terminal sterilisation... Learn about: Clean room design, Pharmaceutical Industry, Sterile Products Manufacture...

...the course then covers process design, pitfalls and associated validation issues including sampling and testing. The course is designed so that the... Learn about: Pharmaceutical Plant Cleaning, Quality Training, Process validation...