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Industry and Science Training Berkshire
- Training
- Reading
- Intermediate
- 1 Day
...methods for producing sterile products. The delegates will gain an appreciation of the significance of sterile products to the patient, and understand... Learn about: Contamination risks, Pharmaceutical Clean Room Operation, Regulatory Compliance...
- Training
- Reading
- Intermediate
- 2 Days
...described in the international standard ISO 19011. Frequent opportunities to practice key steps are provided through role play in a no risk environment... Learn about: ISO 9001, Quality auditing, Pharmaceutical Industry...
- Training
- Reading
- Advanced
- Different dates available
- 3 Days
...and sterility assurance. Course Overview The Qualified Person needs to understand the significance of the presence of bacteria, yeasts, moulds... Learn about: Interpretation of Microbiological Data, Sterile and non-sterile products, Pharmaceutical production operations...
- Training
- Reading
- Intermediate
- Different dates available
- 1 Day
...of the supply chain for their pharmaceutical product from Active Pharmaceutical Ingredients, through excipient sourcing, manufacturing, packaging materials... Learn about: Pharmaceutical manufacturing, Supply Chain Management, Quality management...
- Training
- Reading
- Advanced
- Different dates available
- 3 Days
...Course Overview Qualified Persons cannot fulfil their role in a responsible way unless they understand the actions and uses of the medicinal products manufactured... Learn about: Medicinal Chemistry, Pharmaceutical Products, Pharmacokinetics and Pharmacodynamics...
- Training
- Reading
- Advanced
- Different dates available
- 3 Days
...of pharmaceutical materials. Importantly, it also includes the interpretation of analytical data including non-conforming results and stresses the importance... Learn about: Analytical Chemistry, Analytical method validation, Pharmaceutical manufacturing...
- Training
- Reading
- Advanced
- 2 Days
...the opportunity to learn about the principles of Good Clinical and Good Laboratory Practice, and how these relate to GMP for IMPs. Course Overview... Learn about: Good Manufacturing Practice (GMP), Commerical products, Principles of GCP and GLP...
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The course was well organized and the staff was extremely reliable and competent. I’m totally satisfied with the course and I’m looking forward for next one! I strongly recommend it to anyone who wants to have a deeper understanding of the subject.
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- Training
- Reading
- Advanced
- Different dates available
- 1 Day
...Other modules in the RSSL QP Training Programme are based around the Study Guide, and therefore cover biotechnology products alongside other product types... Learn about: Problem Solving, Biotechnology Issues, Qualified Person (QP)...
...Other modules in the RSSL QP Training Programme are based around the Study Guide, and therefore cover biotechnology products alongside other product types... Learn about: Problem Solving, Biotechnology Issues, Qualified Person (QP)...
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The course was well organized and the staff was extremely reliable and competent. I’m totally satisfied with the course and I’m looking forward for next one! I strongly recommend it to anyone who wants to have a deeper understanding of the subject.
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- Training
- Reading
- Intermediate
- Different dates available
- 1 Day
...SUITABILITY The course is suitable for people who have had some auditor training and experience in conducting audits. It is specifically designed for those... Learn about: Decision Making, Communication Skills, Auditing documentation...
- Training
- Reading
- Intermediate
- Different dates available
- 7 Days
...as required by Directive 2001/83/EC, Directive 2004/27/EC, EU Guidelines on Good Distribution of Medicinal Products for Human Use 2003/C343/01 and... Learn about: Product marketing, Product Analysis, Products Retail...
- Training
- Reading
- Intermediate
- Different dates available
- 2 Days
...over three intensive days. It covers the regulations and guidelines associated with GMPs and the expectations of the MHRA and FDA. Topics examined include incoming materials... Learn about: Quality Training, Goods importation, Goods exportation...
- Training
- Reading
- Intermediate
- Different dates available
- 1 Day
...It is also suitable for anyone who is responsible for responding to inspection findings/deficiencies. Learning Outcomes At the end of the course you... Learn about: Pharmaceutical manufacturing, Regulatory Compliance, Customer Inspections...
- Training
- Reading
- Beginner
- Different dates available
- 1 Day
... understanding of this specialist area. This course is ideal for those new to the pharmaceutical industry working in production, technical support, quality control... Learn about: Microbiological analysis, Pharmaceutical manufacturing, Quality Testing...
- Training
- Reading
- Beginner
- Different dates available
- 1 Day
...It covers responsibilities and terminology (validation, verification, qualification), and looks at the requirements of equipment qualification... Learn about: Pharmaceutical manufacturing, Equipment qualification, Good Manufacturing Practice (GMP)...
- Training
- Reading
- Intermediate
- 1 Day
...the course moves through a series of case study scenarios and the consequent implications. Potential approaches to discharge management responsibilities are explored... Learn about: Management Operations, Auditing documentation, Regulatory Compliance...
- Training
- Reading
- Intermediate
- Different dates available
- 1 Day
...1-day course covers basic issues in cleaning processes in pharmaceutical manufacturing, and the validation of those processes. After an introduction to the overall objectives... Learn about: Pharmaceutical Plant Cleaning, Good Manufacturing Practice (GMP), Analytical method validation...
- Training
- Reading
- Intermediate
- Different dates available
- 1 Day
...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: Best Practice for Documentation, GMP Documentation, Regulatory Compliance...
- Training
- Reading
- Intermediate
- 1 Day
...data trending and how to manage out of limit results. Additionally a review of risks associated with contamination sources, monitoring methods... Learn about: Good Manufacturing Practice (GMP), Identification of non-conformity, Testing results interpretation...
- Training
- Reading
- Intermediate
- 1 Day
... Substance Development) along with its practical application in development, manufacturing, engineering and validation. The course will be aligned to the latest science and risk based principles and regulatory guidances in the EU and... Learn about: Quality Systems, Quality Training, Regulatory Guidelines...
- Training
- Reading
- Advanced
- Different dates available
- 2 Days
...to the Qualified Person and the descriptive statistics used in everyday data analysis of the Pharmaceutical Quality System. Course Overview Evaluation... Learn about: Pharmaceutical Quality System, Interpretation of results, Acceptable Quality Levels (AQLs)...