TypeOnline Course
(1 ratings)
Price$390 / Rs. 19500
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Introduction

Features

Duration

Eligibility

Content

Course Title: KPE’s Certificate Program in in GMP and GMP Audit

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 requiremnt 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

 

Section 1Fundamental of Drug Regulation
Section 2GMP in Pharmaceutical Industry
Section 3Premises - GMP
Section 4Sanitation and Hygiene
Section 5GMP - Equipment
Section 6GMP - Production
Section 7Documentation
Section 8Quality Control
Section 9Product Complaint
Section 10Storage
Section 11QA Detailed Study
Section 12CAPA : Detailed Study
Section 13Internal Audit
Section 14USFDA Warning Letter
Section 15SOP Management
Section 16Product Recall Vs. Market Withdrawal