Reading scientific Services Limited courses

...system and is an essential GMP requirement. It is critical that anyone dealing with GMP documents and documentation systems understand the regulatory requirements... Learn about: Quality Management Systems, Archiving and retrieval, Best Practice for Documentation...

...monitoring programme appropriate for your operations Know how to interpret results and identify trends... Learn about: Manufacturing Process, Good Manufacturing Practice (GMP), Pharmaceutical manufacturing...

...or QA wishing to top up their knowledge of Pharmaceutical Quality Systems. This course can also be run as an in-house course. Learning Outcomes At... Learn about: Regulatory Inspections, Continuous Improvement, Regulatory Compliance...

...GMP and several subjects are explored in detail which helps build up knowledge and confidence in GMP. The range of other standards appropriate to external auditing... Learn about: External auditing, Internal Auditing, Confidence Training...

...experience or for those with experience but who wish to be updated with the latest application, particularly regarding science and risk based principles... Learn about: Good Manufacturing Practice (GMP), Quality Systems, Risk Management...

...against ISO 9001 and the specific GMP standards that have been developed for the supply of packaging, excipient and Active Pharmaceutical Ingredient (API)... Learn about: Pharmaceutical manufacturing, Good Manufacturing Practice (GMP) standards, 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: Monitoring Tools, Problem Solving, Pharmaceutical manufacturing...

...understanding of the MHRA/EU Regulator expectations and how to address and correct actual deficiencies Be familiar with GDP guidelines as covered by... Learn about: Good Manufacturing Practice (GMP), Regulatory Compliance, Deputy Responsible Person...

...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: Responsible Person (RP), Regulatory Compliance, Pharmaceutical Industry...

...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: Regulatory Compliance, Control of Packaging Materials, 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: Qualified Person (QP), Good Manufacturing Practice (GMP), Pharmaceutical manufacturing...

...of data using mathematical and statistical techniques is a key element of controlling the quality of pharmaceutical products for human and veterinary... Learn about: Pharmaceutical Quality System, Pharmaceutical manufacturing, Acceptable Quality Levels (AQLs)...

...trainee QP’s in mind as they need to ensure they understand the plethora of operations and challenges associated with Pharmaceutical Packaging... Learn about: Pharmaceutical manufacturing, Good Manufacturing Practice (GMP), Printed Packaging Components...

...for those who need to ensure they carry out Continuing Professional Development. Learning Outcomes At the end of the course you will: Understand the sources... Learn about: Qualified Person (QP), Good Manufacturing Practice (GMP), Pharmaceutical production operations...

...Any testing performed must be part of a comprehensive ‘Pharmaceutical Quality System’, including QA and GMP, and it must be correctly implemented and controlled... Learn about: Good Manufacturing Practice (GMP), Analytical method validation, Laboratory results analysis...

...can be implemented in the real world. Course Overview The Qualified Person relies on the Pharmaceutical Quality System (PQS) to be able to fulfil their... Learn about: Pharmaceutical Quality System (PQS), Good Manufacturing Practice (GMP), Qualified Person (QP)...

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

...end of the course you will: Understand what is involved in becoming a Qualified Person Understand what makes a ‘good’ QP Know what the opportunities are... Learn about: Becoming a Qualified Person, Assessment process, Opportunities for a QP...

...of the supply chain for their pharmaceutical product from Active Pharmaceutical Ingredients, through excipient sourcing, manufacturing, packaging materials... Learn about: Regulatory Compliance, Supply Chain Management, Pharmaceutical manufacturing...

...Clinical Trials Regulation Cleaning Validation by Toxicity Risk Assessment, updated MHRA Guidance Data Integrity... Learn about: Quality Management Systems, Legislation and guidelines update, Data Integrity...