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Knowledge Excellence (KE) is UK based privately owned consultancy and training company operating all around UK and Internationally. KE is committed to offering the highest quality services, providing second to none training solutions, distinctive support to our clients and to continually improve our services. We use “The Trainer Assessment Programme” (TAP®) Learning System in our unique Blended Learning Wise model which consists of 3 exclusive learning elements (TAP®, Game Based Learning [GBL] and the use of Performance Response System Technology in the training quizzes-[PRS]). For enhanced retention all our courses are professionally designed in short palatable sessions with additional individual interactive sessions.
The use of TAP® Learning System, GBL and PRS by our highly qualified Subject Matter Experts guarantees that all our courses will be; informative, participative, enjoyable, inspiring and have long lasting results. All our courses are measured by a final evaluation assessment questionnaire. Knowledge Excellence offers tailored on site training to give delegates a chance to take an intense look at very specific issues in their work focusing on the precise requirements of your organization. E-learning courses are available on request.
Developing a Successful Training Programme is increasingly becoming an essential requirement to satisfy regulatory agencies in the USA and Europe.
- FDA’s quality system regulation [21CFR 820.25(b)] Training, states, “ Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented (1) As part of their training, personnel shall be made aware of device defects which may occur from improper performance of their specific jobs. (2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job performance.”
- ISO 9001:2000 [Clause 6.2.2], states,” Organsiations shall (a) determine the necessary competence for personnel performing work affecting product quality,(b)Provide training or other actions to satisfy these needs, (c) evaluate effectiveness of the actions taken, (e) maintain appropriate records of education, training, skills and experience.”
- ANSI/ISO/ASQC Q9001-1994 states, “Personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training, and/or experience, as required.”
Whether you want to get FDA approval or CE mark [93/42/EEC] for your product an effective training programme is one of your major routes to success. We use real examples of non-compliance reports to maximize the training benefits. Knowledge Excellence quality continuing technical education courses are designed to be practical,different and discovery-oriented.
Knowledge Excellence works with clients to:
- Get faster regulatory approval
- Avoid project delays
- Reduce costs by decreasing wasted time in re-works, and materials
- Increase accuracy and efficiency
- Improve reputation
Knowledge Excellence Technical & Regulatory Learning &Development Solutions:
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Good Laboratory Practice (GLP-OECD and FDA)-Foundations
The main objective of this course is to give an overview of the requirements imposed by Good Laboratory Practice (GLP) regulations. Manufacturers from pharmaceutical and medical device industries have to comply with the various GLP regulations, according to the destination countries of their products. This course concentrates on OECD Good Laboratory Practice guidelines with a brief comparison to FDA GLP regulations.
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Good Manufacturing Practise (cGMP)- Foundations
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Current Good Manufacturing Practice (cGMP) requirements are intended to ensure the safety, effectiveness of medical devices. The GMP requirements are harmonized with the International Organization for Standards (ISO) 9001:1994 and ISO 13485. The prime focus of GMP regulations is on building quality at the earliest stages of manufacturing to prevent errors, mix ups, eliminate contamination and all areas that can have significant effects on the quality, safety and effectiveness of the device. This 3 days course focus on US cGMP regualtions and aims to help delegates to have an in-depth understanding of cGMP requirements, its practical implementations and strategies for compliance.
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Documentations requirement for CE and 510K submissions-All what you need to know
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ISO10993: Biocompatability Evaluation of medical devices-An Introduction
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Technical Report Writing
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Clean rooms testing-The Basics
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Microbiology the Basics
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Limulus Amebocyte Lysate (LAL)
Bactericidal procedures such as heating, filtration and sterilization techniques do not eliminate pyrogens from parenteral solutions or medical devices. Good practice is for the manufacturer to recognize the critical steps in the manufacturing operations that could allow the growth of pyrogen producing bacteria, to include control of microbiological and endotoxin level contamination in the potential sources and monitor these areas routinely.
Final product endotoxin testing on all parenterals and medical devices is a requirement by The FDA and US Pharmacopoeia Standards. This comprehensive 2 days course aims to introduce the participants to the practical approaches of LAL methodologies, with a review of the regulatory requirements, limitations /interfering factors, documentations, depyrogenation and product submission.
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Aseptic techniques-Quality Map
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At the Bench- Laboratory Skills for Microbiologists
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At the Bench-Laboratory Skills for Chemists
- Laboratory Skills for Chemists-Course details
All our courses are delivered Worldwide in English language. Multilingual courses are available upon request. For more details on any of the above courses please contact us using the contact us form giving your name, company name, enquiry and a contact number, we will get back to you within 48hours. For future open course schedule please click Open Course |
