Certification Course Overview
Professional certificate Program in Pharma quality control, assurance and regulatory affairs
Pharmaceutical quality control, assurance, and regulatory affairs certification courses teach students about the regulations and responsibilities of these roles in the pharmaceutical industry.
Course Duration: 3 Months
Mode: Online/Hybrid
Key Features
Certificate of program completion from the Rapture Biotech International Pvt. Ltd.
Exclusive hackathons and “ask-me-anything” sessions by Rapture Biotech.
Curriculum delivered in live online classes by experienced field veterans.
It helps you get noticed by top hiring companies.
What you'll learn
Syllabus
- Overview of GMPs & GLPs
- Quality Management: Principles, Quality Assurance, Quality Control
- Sanitation & Hygiene
- Contract Production & Analysis
- Packaging of Dosage Forms: Aspects, Functioning
- Documentation Methods
- Quality Assurance Aspects of Packaging
- Quality Specifications
- Overview of Drug Regulation
- About the NIHFW
- Regulatory Affairs Regarding Drug Regulation
- Introduction to Regulatory Requirements Theory
- Generic Drug Development
- Introduction
- Drug Approval Process in India & Worldwide
- Legislative History of Drug Regulation
- How FDA Approves New Drugs
- FDA Drug-Regulation Activities
- Introduction, Early Studies of Drug Discovery
- Non-Clinical Trials
- Introduction, Historical Perspectives
- Quality Management System (QMSs)
- Pharmaceutical Quality Management System
Companies Hiring






















Trainer’s Profile & Program Advisors

Dr. Sunil K. Arora
Dr. Sunil K. Arora is a Consultant Scientist at Rapture Biotech and a highly accomplished former Additional Director (Scientist Level-V) at the Central Research Institute, Kasauli, with over 30 years of experience in immunobiologicals, toxicology, metabolism, and communicable diseases. His expertise extends to the production, quality control, and testing of vaccines and antisera, including anti-snake venom, anti-rabies, and anti-COVID-19 serum. Dr. Arora has made substantial contributions to public health through his research, evidenced by over 40 publications in renowned national and international journals.

Dr. Sanchita
Dr. Sanchita Sharma holds a doctorate in microbiology. She spent at least two years working on different administration and management profiles at Rapture Biotech Noida (Head office), ranging from entry-level to mid-management level. She has five research papers published in national and international journals that are peer-reviewed. She is the director of Rapture Biotech, Gwalior, at the moment. She completed her master's degree at Gwalior, Madhya Pradesh's ITM University. She is a young professional who is enthusiastic about the potential and challenges that lie ahead in the field of biotechnology. She also has a strong love of learning. She is lagging behind in embracing cutting-edge biotech innovations.
Job Profiles
Quality Assurance Specialist
Pharmaceutical Research Scientist
Pharmaceutical Chemist
Medical Writer
Regulatory Affairs Specialist
Pharmaceutical Sales Representative
Who can apply for this course?
Persons pursuing or passed out of M.B.B.S, BDS, B.Sc., M.Sc., B.Tech, M.Tech, Ph.D. in Biotechnology, Bioinformatics, Microbiology & other relevant qualifications and Corporate employees in the respective areas are eligible.
Course Fees
Duration | Indian | International |
3 months | 30,000 | 700 USD |
Note:
Customized trainings are also available.
Special discounts are offered.
EVALUATION & AWARD OF CERTIFICATE
- Select Distance Learning Program of your choice.
- Fill online application form & Pay fees.
- Confirmation of admission & enrolment number.
- Transfer of Course material via E-mail.
- Download & submit Assignment.
- Evaluation.
- Award of Certificate based on performance in Assignment.
HOW TO APPLY
Step 1 – Click on “Apply Online Form from the website.
Step 2 – Completely fill the application form and submit online.
Step 3 – Submit application fee using:
For Indian students:
- NEFT from anywhere in India or Pay Via Phone Pay (9910181655).
- Name of the Account: Rapture Biotech International Pvt. Ltd.
- Account Number: 2612431210
- IFSC Code: KKBK0005033
For International Students:
- Bank to Bank Transfer by Swift Mode.
- Bank Name: Kotak Mahindra Bank, Sec-18, Noida
- Name of the Account: Rapture Biotech International Pvt Ltd
- Account Number: 2612431210
- Swift Code: KKBKINBB
- IFSC Code: KKBK0005033
Important Links
Contact Us
We are India's
