TypeOnline Course
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Price$490 / Rs. 27500
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GMP and GMP Audit Course by www.nckpharma.com

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.

1 Month

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

Section 1Course Introduction : Fundamental Understanding
Lecture 1Certification Manufacturing Companies and Manufacturing Plan
Lecture 2Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning 
Lecture 3WHO-GMP Certification Scheme
Lecture 4Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 2GMP - Modules
Lecture 5G1 Lecture Premises & Plant Layout Designing
Lecture 6G2 Lecture Sanitation and Hygiene
Lecture 7G3 Lecture Equipment Modules
Lecture 8G4 Lecture Production Modules
Lecture 9G5 Lecture Documentation
Lecture 10G6 Lecture Quality Control
Lecture 11G7 Lecture Product Complaint
Lecture 12G8 Lecture Storage Module
Lecture 13Product Recall | Product Withdrawal | Types of Recall | Handling and Management of Product Recall
Lecture 14Pharmaceutical SOPs Management from regulatory perspective
Lecture 15Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Section 3Advance Learning
Lecture 16GMP & USFDA Warning Letter
Lecture 17GMP & Data Integrity
Lecture 18Handling of warning letter
Lecture 19Case Study : Warning Letter
Lecture 20Implementation of CAPA in managing GMP