Course Title: RYD-045
Course Code: Advance Certification in GMP & GMP Audit Management
Course Type: Online
Course Duration: 1 Month
Requirements: Access to a computer with an internet connection.
- 24×7 self paced learning.
- E-lecture – Instructor enabled.
- Simulation and case studies
- Self assessment tests.
- Online online final examination
Certificate of Completion: Yes, will be issued at the completion of the course.
Certificate of merit: Yes, will be issued at the end of the completion of the final examination.
Hours of Training: 30 Hours of Training
Self Assessment Tests:
Course Handout in PDF form: Yes, it can be downloaded and save.
Who should attend this course:
- Regulatory Affairs Professionals
- QA / QC person involving in plant audit
- Those who are handling plant audit
- External Audit Consultant
This online GMP training course utilizes interactive learning tools to guide each participant through the steps of the drug development process. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
The GMP course can be completed at any pace, allowing the user to stop and start at their leisure.
This course is divided into following modules
1. Quality : definition, evolution, attributes, concept and specific aspects for pharmaceutical products
2. GMP and its relationship with quality basics to specifics, History of GMP and its evolution and progress,
Progress of GMP with current status regulatory status and trends of various regulatory agencies with important milestones
3. GMP regulations and standards
4. Requirements, scope, objective and principles and practices of GMP with emphasis on GMP requirements of WHO ,TGA, MHRA, MCC, HPFBI, PICS, EU, ICH, USFDA and the new Schedule M.
5. Obtaining International GMP Certification and maintaining the GMP continuum.
6. Principles of Quality Assurance and Quality management Systems
Principles and Practices of Good Laboratory Practices,
7. Good Documentation Practices, water systems, stability studies,
8. Advances in GMP, Training and Auditing in GMP, Handling international GMP audits effectively and successfully,
Implementing GMPs in your organization, and getting the most out of quality by maintaining the GMP continuum.
9. GMP Audit