Course Code: KPE-C-011
Course Title: KPE’s Certificate Program in in GMP and GMP Audit
Course Type: Online, distance learning
Course Objective: The objective of this course is to impart knowledge and understanding GMP, C-GMP requirement of the pharmaceutical manufacturing plant and managing audit procedure to maintain the same.
1. Orientation to practical understanding in the entire GMP and C-GMP requirement and handling and managing GMP Audit.
2. Simulation to real life Strategic planning in GMP and GMP Audit.
3. Access to Industry Databank
4. Access to GMP related case studies
5. Attend Live Lectures of all different chapters / study content.
B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.
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
10. Detailed understanding in USFDA warning letters and handling of cGMP related warning letter.
11. Detailed understanding and training data integrity and management of data integrity in pharmaceutical and biopharmaceutical industry