Training in Reading

...It covers responsibilities and terminology (validation, verification, qualification), and looks at the requirements of equipment qualification... Learn about: Cleaning validation, Analytical method validation, Equipment qualification...

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

...scenarios built around common issues observed by auditors and regulatory authorities. Many companies find it can be even more effective run as an ‘in-house’ course... Learn about: Management Operations, Auditing documentation, Good Manufacturing Practice (GMP)...

...and understand why there is intensive regulatory interest worldwide in the control of sterile product manufacture. Course Overview This course provides... Learn about: Quality Training, Good Manufacturing Practice (GMP), Aseptic filling and terminal sterilisation methods...

...out the important operation of ‘Walking the Plant’ Recognise good and bad practices Be able to calculate acceptance criteria Be able to clearly identify... Learn about: Quality Training, Process validation, Pharmaceutical manufacturing...

...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: Quality auditing, Quality Management Systems, Pharmaceutical manufacturing...

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

...end of the course you will understand: The relationship between ICH Q10 (Pharmaceutical Quality Systems) and the EU Guide for GMP (Volume... Learn about: Good Manufacturing Practice (GMP), Pharmaceutical manufacturing, Key Performance Indicators (KPIs)...

...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: Pharmaceutical Industry, ISO 19011, ISO 9001...

...and expectations Understand how ICH Q9 underpins ICH Q8, Q10 and Q11 for activities in development, manufacturing, engineering and process validation Understand... Learn about: Risk Management, Good Manufacturing Practice (GMP), Quality Training...

...auditors to converse in the language that is universally used by its suppliers. On successful completion of this course, delegates may apply for professional... Learn about: ISO 9001, Pharmaceutical Quality Group (PQG), Quality Training...

...Learning Outcomes By the end of the course you will be able to: Understand what human error is Understand why errors occur Understand how we learn Recognise... Learn about: Human Behaviour, Learning Processes, Good Manufacturing Practice (GMP)...

...Fully reviewing Good Distribution Practice (GDP) as required by Licence Holders, it provides an understanding of the key GDP Quality Systems required... Learn about: Good Manufacturing Practice (GMP), Supply Chain Management, Licence Holder...

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

...the requirements of Good Manufacturing Practice. Suitability An essential course for all those who expect to be taking the QP viva, it is also a valuable... Learn about: Process and Cleaning Validation, Pharmaceutical manufacturing, Regulatory Compliance...

...The lectures are provided through subject matter experts and supported by worked manufacturing and packaging examples and experiences provided by... Learn about: Pharmaceutical Products, Pharmacokinetics and Pharmacodynamics, Medicinal Chemistry...

...to the Qualified Person and the descriptive statistics used in everyday data analysis of the Pharmaceutical Quality System. Course Overview Evaluation... Learn about: Data analysis, Interpretation of results, Pharmaceutical manufacturing...

...from component manufacture and supply to final product release including QP certification. Suitability This course has been designed specifically... Learn about: Quality Systems, Printed Packaging Components, Pharmaceutical manufacturing...

...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: Interpretation of Microbiological Data, Good Manufacturing Practice (GMP), Pharmaceutical Industry...

...of how these need to be managed. All activities are discussed and explained within the confines of current Good Quality Control Laboratory Practice... Learn about: Good Manufacturing Practice (GMP), Pharmaceutical manufacturing, Qualified Person (QP)...