Training in Berkshire

...the regulatory system, the marketing of a device and the ISO 13485 Medical Device Standard. Added to this there is an introduction to risk management and the vigilance system... Learn about: Quality Testing, Pharmaceutical manufacturing, Quality Training...

...of projects within budget and on time. Benefits for the delegate: Makes the move into project management easier. Improves effectiveness and credibility...

...out in GMP both in the European and USA regulations and guidance documents. The pharmaceutical quality control laboratory serves one of the most important... Learn about: Quality Training, Laboratory Practice, Pharmaceutical manufacturing...

...architecture and the CSA MC · Configure the way CSA protects a host system · Install CSA with a default Agent kit · Create host groups and build Agent...

...Suitability The course is suitable for people who are responsible for preparing external inspections and those requiring knowledge and understanding of the inspection process... Learn about: Inspection Process, Pharmaceutical manufacturing, Inspection Observations...

...Getting Started with Cisco Security Appliances · Four main access modes · Security appliance file management system · Security appliance security levels...

...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: Microbiological analysis, Pharmaceutical manufacturing, Quality control...

...The exam can be booked with us at an additional charge and taken at an exam venue in the UK at a later...

...The course also examines the documentation and project management aspects of validation studies. The need for effective change management and life-cycle... Learn about: Analytical method validation, Cleaning validation, Good Manufacturing Practice (GMP)...

...tailoring the case studies around their own specific audit findings, and engaging personnel from different levels within the organisation... Learn about: Quality management, Quality Systems, Auditing documentation...

...and terminal sterilisation methods for producing sterile products. The delegates will gain an appreciation of the significance of sterile products to the patient... Learn about: Regulatory Compliance, Sterile Products Manufacture, Clean room design...

...what constitutes ‘visually clean’ Be aware of the issues surrounding sampling and testing techniques Appreciate the importance of analytical method validation... Learn about: Quality Training, Analytical method validation, Pharmaceutical Plant Cleaning...

...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: Best Practice for Documentation, Pharmaceutical manufacturing, Best Practice...

...techniques employed to monitor pharmaceutical environments, data trending and how to manage out of limit results. Additionally a review of risks associated... Learn about: Identification of non-conformity, Good Manufacturing Practice (GMP), Environmental Monitoring...

...maintenance and monitoring of the Pharmaceutical Quality System (PQS). This is the first time that European guidance explicitly articulates the wide-ranging... Learn about: Pharmaceutical Quality System (PQS), Key Performance Indicators (KPIs), Continuous Improvement...

...up knowledge and confidence in GMP. The range of other standards appropriate to external auditing (e.g. GDP, ISO 9001) are described briefly but not explored in depth... Learn about: Internal Auditing, ISO 19011, Quality auditing...

...the principles of QRM, the ICH Q9 framework and the importance of common language and approaches, and the differences between QRM and risk analysis Understand... Learn about: Regulatory Guidelines, Quality Risk Management (QRM), Pharmaceutical manufacturing...

...it applies to auditing of suppliers Understand how to apply the appropriate standards for auditing pharmaceutical suppliers: PS9000 for packaging components... Learn about: Regulatory Compliance, Quality Training, Internal/External Audits...

...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: Problem Solving, Learning Processes, Monitoring Tools...

...Fully reviewing Good Distribution Practice (GDP) as required by Licence Holders, it provides an understanding of the key GDP Quality Systems required... Learn about: Responsible Person (RP), Quality Training, Pharmaceutical Industry...