Why gmp training

Learn more about Communities of Practice. Special Reports. Let's talk. Next Course. Jan 26 - Jan 28, Virtual to CST. Course Director. Kerry Potter. Course Fee. Course Brochure. Click to download course brochure. Apr 6 - Apr 8, Virtual to EDT. PharmaTrain Recognized Course.

Course Description. Why This Course Matters. Who Should Attend. Learning Objectives. Be able to understand and apply GMP concepts to decision making in a managerial role Understand facility and equipment design implications on the final product Know and understand the difference between commissioning, qualification and validation and how, where and why they are applied Become knowledgeable of the GMP Risk Management approach for the 21st Century and how it applies to international harmonization Know how to better locate regulatory information and interpret, assess, and make decisions concerning GMP issues.

Great training" Carlos, Mfg. I learned a lot. Thank you" Karla V. I found the Course Director did a wonderful job in keeping us interested in the subject" Mercedes S. Is the course content too detailed for someone with no or only a limited understanding of pharmacokinetics and drug metabolism?

Will information be provided on the nonclinical and clinical pharmacokinetic and drug metabolism studies required by the regulatory agencies? Will pharmacokinetic and drug metabolism requirements for macromolecules be provided? Will discovery lead optimization studies be discussed?

Does the course require detailed knowledge of mathematics, such as integral calculus, to understand the pharmacokinetics to be presented? Certification Tracks. Related Courses. The following recommendations will help make the GMP training fun and engaging more appropriate. To ensure training effectiveness, it's not enough to simply have the employee sign a sign-in sheet. In no way does it provide information about the retention of knowledge gained through the program.

End-of-course tests are highly effective in evaluating training effectiveness. Compiling the data of the test will help you determine the overall effectiveness and work on areas of improvement. Training programs must be well documented and thorough.

SOPs defining these programs are a requirement. The training program development must include:. By using this site you agree to our use of cookies. Please refer to our privacy policy for more information. Why GMP Training? Samantha Clack - A working QP, lead auditor and QP trainee coordinator, Samantha has an up-to-date knowledge of GMP requirements and hands-on experience of how to implement and meet regulatory expectations.

David Waddington - David has broad experience in QA and manufacturing management, working with a wide range of different dosage forms for global supply including solids, liquids, sterile products, food supplements and natural products. Catherine Kay - Catherine has extensive pharmaceutical operations management, technical and QA experience spanning more than 23 years, gained working for a major international pharmaceutical organization, a start-up manufacturing organization and, most recently, a contract manufacturing organization in a corporate operations role.

A-Z of Sterile Products Manufacture. Whether you need to meet EU, FDA or other regulations, this course provides the knowledge, skills and tools to succeed. Looking for certified products and systems instead? Virtual Learning. About This Course It is a legal requirement that all staff members receive Good Manufacturing Practice GMP pharmaceutical training as well as regular updates thereafter.