Reading scientific Services Limited courses

...of what to do when managing GMP documentation and documentation systems. Course Overview Documentation is the cornerstone of any company’s quality management... Learn about: GMP Documentation, Quality auditing, Best Practice for Documentation...

...Understand the testing techniques regularly used in pharmaceutical production operations Know what factors to consider when developing an environmental... Learn about: Environmental Monitoring, Good Manufacturing Practice (GMP), Testing techniques...

...and develop an action plan to facilitate delivery in their organisations. Course Overview Recent changes to the EU Guide to GMP emphasise theimportance... Learn about: Pharmaceutical manufacturing, Quality Training, Senior Management Responsibilities...

...Suitability This course is suitable for people who are about to start auditing or who may already undertake some auditing, but have not yet had any formal training... Learn about: ISO 19011, Pharmaceutical Industry, ISO 9001...

...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: Pharmaceutical manufacturing, Good Manufacturing Practice (GMP), Regulatory Guidelines...

...materials to the pharmaceutical industry. ISO 9001 is covered in detail and this will enable pharmaceutical auditors to converse in the language that... Learn about: Quality Management Systems, Internal/External Audits, Pharmaceutical Quality Group (PQG)...

...in the background to human errors and those seeking techniques to proactively target to design, implement and monitor human error programs within their businesses... Learn about: Good Manufacturing Practice (GMP), Pharmaceutical manufacturing, Monitoring Tools...

...for pharmaceutical products, the course is aimed at RP’s, Deputy RP’s or those planning to become an RP. It would also benefit quality managers... Learn about: Regulatory Compliance, Deputy Responsible Person, Responsible Person (RP)...

...Directive 2004/27/EC and the EU Guidelines on Good Distribution of Medicinal Products for Human Use 2013/C 343/01. In particular it examines the implications of the changes... Learn about: Licence Holder, Regulatory Compliance, Deputy Responsible Person...

...with importation requirements as defined in the Falsified Medicines Directive. This course includes both the technical aspects of manufacturing APIs... Learn about: Manufacturing API's, Supply Chain Management, Good Manufacturing Practice Standards...

...Suitability An essential course for most QP candidates, including those with a little prior knowledge of pharmacology. Provides a useful contribution... Learn about: Pharmaceutical manufacturing, Pharmaceutical Chemistry, Qualified Person (QP)...

...provide detailed instruction in complex statistical techniques, rather it concentrates on the interpretation and understanding of results as they are presented... Learn about: Data analysis, Quality Assurance, Pharmaceutical Quality System...

...relevant to the QP, from component manufacture and supply to final product release including QP certification. Course Overview The QP needs to fully understand... Learn about: Regulatory Compliance, Packaging Operations, Qualified Person (QP)...

...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: Interpretation of Microbiological Data, Microbiology of water, Good Manufacturing Practice (GMP)...

...be part of a comprehensive ‘Pharmaceutical Quality System’, including QA and GMP, and it must be correctly implemented and controlled. This module reviews... Learn about: Quality Control Laboratory Testing, Laboratory results analysis, Stability Testing...

...end of the course you will know and understand: The key role the PQS plays in ensuring quality and compliance The key elements of a PQS The role of... Learn about: Pharmaceutical Quality System (PQS), Regulatory Compliance, Quality Training...

...and the unique additional GMP requirements for IMPs. This two day interactive course examines the EU legislation relevant to the manufacture... Learn about: GMP requirements for IMPs, Investigational Medicinal Products (IMPs), Principles of GCP and GLP...

...this is the ideal opportunity for you to learn more about what is involved and decide on your next steps. Our QP Roadshow events are suitable for anyone... Learn about: Training Programme, Opportunities for a QP, Good Manufacturing Practice (GMP)...

...How do I keep the supply chain map up to date? What must be included in the supply chain map, how do I assess the risk? How do I ensure the QP has access?... Learn about: Supply Chain Management, Supply Chain mapping, Pharmaceutical manufacturing...

...guidelines for control of manufacture of medicines in the EU. This will help you ensure that all requirements are implemented in a practical and effective manner... Learn about: Pharmaceutical manufacturing, Legislation and guidelines update, Regulatory Compliance...