Training in Reading

...management will be discussed. Course Overview The course provides an overview of the concept of validation as described in Annex 15 to Eudralex Volume... Learn about: Regulatory Compliance, Good Manufacturing Practice (GMP), Pharmaceutical manufacturing...

...To show how to minimise Problems and Delays when handing over a Project. Suitable for: Newly appointed Project Managers or Project Leaders. Project Managers...

...into sharp focus the management responsibilities for implementation and assessment of quality systems within an organisation. Most notably the changes... Learn about: Quality Training, Good Manufacturing Practice (GMP), Management Operations...

...working in sterile products manufacturing, QC (especially environmental monitoring personnel), QA personnel as well as support engineers. Learning Outcomes... Learn about: Regulatory Compliance, Contamination risks, Good Manufacturing Practice (GMP)...

...1-day course covers basic issues in cleaning processes in pharmaceutical manufacturing, and the validation of those processes. After an introduction to the overall objectives... Learn about: Process validation, Analytical method validation, Good Manufacturing Practice (GMP)...

...Learning Outcomes At the end of the course you will: Understand the GMP rules and guidelines associated with the preparation, completion and archiving... Learn about: Archiving and retrieval, Good Manufacturing Practice (GMP), Quality auditing...

...their understanding of regulatory requirements and expectations for the environmental monitoring of pharmaceutical operations. It will be of particular... Learn about: Testing results interpretation, Environmental Monitoring, Manufacturing Process...

...Recent changes to the EU Guide to GMP emphasise the importance of Senior Management involvement and commitment in the design, implementation... Learn about: Quality Training, Continuous Improvement, Pharmaceutical manufacturing...

...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, Quality auditing, Pharmaceutical Industry...

...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: Regulatory Guidelines, Risk Management, Risk analysis techniques...

...universally used by its suppliers. On successful completion of this course, delegates may apply for professional recognition as an IRCA certified QMS Lead Auditor... Learn about: Internal/External Audits, Pharmaceutical Quality Group (PQG), ISO 9001...

...This course is designed to provide an understanding of why we create errors, how the human brain operates and learns and tools, techniques and approaches... Learn about: Human Behaviour, Problem Solving, Good Manufacturing Practice (GMP)...

...Directive 2004/27/EC, EU Guidelines on Good Distribution of Medicinal Products for Human Use 2013, and the new requirements included in the MHRA 2014 Orange and Green Guides... Learn about: Licence Holder, Quality Systems, Supply Chain Management...

...as required by Directive 2001/83/EC, Directive 2004/27/EC and the EU Guidelines on Good Distribution of Medicinal Products for Human Use 2013/C 343/01... Learn about: Quality Systems, Deputy Responsible Person, Responsible Person (RP)...

...Directive and APIs How to use the European Guide to GMP for APIs The contents of a Drug Master File Methods and equipment used in synthesis Requirements for specifications... Learn about: Supply Chain Management, Active Pharmaceutical Ingredient (API), Manufacturing API's...

...The lectures are provided through subject matter experts and supported by worked manufacturing and packaging examples and experiences provided by... Learn about: Pharmacokinetics and Pharmacodynamics, Good Manufacturing Practice (GMP), Pharmaceutical manufacturing...

...The Qualified Person must understand the derivation and application of the data with which they will be presented. This course focuses on the practical... Learn about: Acceptable Quality Levels (AQLs), Pharmaceutical manufacturing, Interpretation of results...

...The QP needs to fully understand the challenges and risks involved in packaging operations in the Pharmaceutical Industry. A significant percentage... Learn about: Regulatory Compliance, Qualified Person (QP), Packaging materials...

...is one of a series of modules designed specifically to satisfy the requirements of the QP study guide. It is a popular module for trainee QPs who are non microbiologists... Learn about: Pharmaceutical Industry, Qualified Person (QP), Pharmaceutical production operations...

...It has been recognised for many years that the sampling and testing of materials does not by itself assure product quality. Any testing performed... Learn about: Pharmaceutical manufacturing, Stability Testing, Qualified Person (QP)...