InstructorRoyed Training
TypeOnline Course
Price$90 / 4950 INR.
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WHO GMP Certification Scheme

Introduction

Course Type

Course Duration

Eligibility

Who should attend

Certification

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About WHO GMP Certification Scheme

cpp and who gmp certification scheme

This training provides fundamental understanding and requirements of WHO Certification Scheme and Certificate of Pharmaceutical Product. This online training explores WHO guidelines and relevant local legislative requirements for WHO GMP Certification and CPP. This training aims to provide a greater understanding of the export requirement of the pharmaceuticals.

The WHO Certification Scheme for Certificates of Pharmaceutical Products (CPP) is an international voluntary agreement to provide assurance for countries participating in the Scheme about the quality of pharmaceutical products moving in international commerce. More than 130 countries are member states of the Scheme or acknowledge and accept the Scheme. However, WHO GMP Certification Scheme is not harmonized to a large extent.

In this online self-paced modules, participant will be understanding about the country specific requirements of the WHO GMP Certification Scheme. The course provide valuable insight on Certificate of Pharmaceutical Product, it’s template, significance. Moreover, course provides detailed insight on how to work on certification of pharmaceutical product with real life case studies.

Course Code: RYD-095

Course Title: Fundamental Training in WHO GMP Certification Scheme

Online micro learning course. So, course can be accessed online across anywhere 24×7.

Duration: 3 Days

Any body who wants to acquire detailed understanding certificate of pharmaceutical product product and WHO GMP certification scheme.

Any body who wants to acquire competency regarding new drug development process, should attend the course.

Who should attend this course? 

  • This course is ideal for those who requires detailed pharmaceutical export. For example, those working in Regulatory Affairs, Pharmaceutical International Business Development, Production Management professionals.
  • Fresher/Beginners, Those who want to make a career in pharmaceutical international business.
  • Moreover, this Bioavailability and Bioequivalence study will be ideal for R&D managers, Regulatory Affairs Executives and Managers, Formulation managers, Production Manager, International Business Manager etc.

Certificate will be provided at the end of the successful completion of the course

  • WHO-GMP certification Scheme.
  • Detailed understanding of CPP.
  • Significance and importance of Certification of Pharmaceutical Product.
  • Different types of CPP.
  • Format of CPP. Different section – how to work on CPP.
  • USFDA CPPs.
  • FSC and CPP difference.
  • CPP Scheme for generic submission.
  • Plant inspection as a part of CPP scheme.
  • Case discussion.
  • Country and regions who requires CPP.

The WHO Certification Scheme for Certificates of Pharmaceutical Products (CPP) is an international voluntary agreement to provide assurance for countries participating in the Scheme about the quality of pharmaceutical products moving in international commerce.
The Scheme was originally endorsed in 1969 as a powerful instrument to assist National Regulatory Authorities (NRAs) in sharing information and avoiding duplication. This key principle still holds true. However, since 1997 the scheme has not changed despite dramatic changes in the regulatory environment within both the issuing and recipient CPP markets.

In this course we explore the WHO-GMP Scheme. How WHO GMP certification scheme operates and influences patient access to medicines. In fact, the course also provides the key observations and recommendations how to work on WHO GMP Certification scheme.

Section 1
Lecture 1Introduction 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 2WWHO-GMP Certification Scheme 
Lecture 3Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 2Final Examination

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