Training in Berkshire

...in the pharmaceutical industry where medical device regulations are applied - e.g. for inhalers, pre-filled syringes, infusion bags etc. Learning Outcomes... Learn about: Medical Device, Regulatory Compliance, Pharmaceutical manufacturing...

...To show how to use a range of Planning Tools to identify the Critical Path. To demonstrate how to use the appropriate methods of Monitoring a Project's progress...

...laid 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: Pharmaceutical manufacturing, Quality Training, Laboratory Practice...

...Windows NT operating system. · Familiarity with implementing network security policies and networking concepts What's included? Our package includes full course materials...

...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 Observations, Regulatory Compliance, Inspection Process...

...· Object grouping feature of the security appliance and its advantages · Configure object groups and use them in ACLs Switching and Routing on Security...

...technical support, quality control and quality assurance roles. In addition, it will also be of benefit to maintenance and support engineers who are involved... Learn about: Quality Testing, Good Manufacturing Practice (GMP), Quality control...

...· This course is also recommended for anyone pursuing any of several certification opportunities, including · · Cisco Certified Security Professional (CCSP)...

...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: Analytical method validation, Cleaning validation, Regulatory Compliance...

...The revision of Chapter 1 (Quality Management) and Chapter 2 (Personnel) of Part I of the EU guide to GMP to incorporate ICH Q10 brings into sharp focus... Learn about: Quality Systems, Management Operations, Good Manufacturing Practice (GMP)...

...working in sterile products manufacturing, QC (especially environmental monitoring personnel), QA personnel as well as support engineers. Learning Outcomes... Learn about: Aseptic filling and terminal sterilisation methods, Quality Training, Regulatory Compliance...

...important and fundamental issues associated with cleaning validation or verification are broken down and explained. Numerous practical exercises are run throughout... Learn about: Sampling and testing techniques, Pharmaceutical manufacturing, Pharmaceutical Plant Cleaning...

...and adopts best practice. As such this course provides a step by step explanation of what to do when managing GMP documentation and documentation systems... Learn about: Archiving and retrieval, GMP Documentation, Quality auditing...

...with contamination sources, monitoring methods, trending and reporting of results is undertaken. Course Overview The course addresses environmental monitoring... Learn about: Good Manufacturing Practice (GMP), Testing techniques, Identification of non-conformity...

...This is the first time that European guidance explicitly articulates the wide-ranging role of Senior Management beyond the Heads of QA and Production and the Qualified Person... Learn about: Regulatory Compliance, Quality Training, Good Manufacturing Practice (GMP)...

...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: Pharmaceutical Industry, Quality auditing, Confidence Training...

...risk ranking, cause-effect matrix and other related Risk Analysis techniques, such as process flow diagrams, ‘fishbone’, ‘brainstorming’ etc Appreciate... Learn about: Quality Risk Management (QRM), Regulatory Guidelines, Quality Training...

...the delegate with a qualification in auditing that is recognised by the International Register of Certified Auditors (IRCA) and the Pharmaceutical Quality Group (PQG)... Learn about: Quality Management Systems, Internal/External Audits, Good Manufacturing Practice (GMP) standards...

...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: Learning Processes, Good Manufacturing Practice (GMP), Monitoring Tools...

...Course Overview This intensive 2-day course evaluates the key roles and responsibilities of the Responsible Person (RP) and Deputy RP in relation to Directive 2001/83/EC... Learn about: Regulatory Compliance, Pharmaceutical Industry, Good Distribution Practice (GDP) Guidlines...