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Regulatory Affairs

Pharma Regulatory Regime in USA, EU and Canada
Pharmaceutical Legislation
Regulatory Bodies
Import of Drugs in USA
Export of Drugs from USA
Licensing in Europe
Regulations in Canada

Introduction to Pharmaceutics
Introduction to Pharmaceutical drugs and Products
Classification
Testing
Introduction to Pharmaceutical Chemistry
Industrial Application

Pharma Regulation Practices and Procedure
Pharma Regulatory Affairs
Drug Regulatory Authorities
Good Manufacturing Practices
Regulations of Pharmaceutical products
Regulations of Alternative Systems of Medicine
Bioethics
Regulatory profession

GMP, Quality Assurance and Regulation
Introduction
Overview of Good Manufacturing
Practices
International GMP Regulation
Indian GMP Regulation
Quality Assurance

Regulatory Compliance for Pharma and Biotech Products
Regulatory Compliance in USA
Orphan Drugs
Regulatory Compliance in Canada and Other Countries
Drugs and Magic Pharmaceuticals Production in Transgenic Animals
Future of Compliance-an efficient and effective Commercial Operation
Strengthening Governance and Regulatory Compliance

The Trainers

Heny Tang
Senior HACCP Trainer
QA Manager
MSc. CQE, CQA, CHA, CSSBB

Rupali Sanas
Senior HACCP Trainer
QA Manager
MSc. CHA, BRC Certified Auditor

The Achievements
Achievement
Consultation

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The Resources
Resources
Articles
Articles
OCOT Hotline

(phone) 416-332-8727

ACCPAC

OCOT Advantages

100 %Instructor-Led Class
State-of-the-Art Facilities
Unlimited Lab Time
Labs Open 7-days a Week
Free Repeat
Free Job Placement
Financial Aid Possible
Resume Writing
Interview Skills


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