Certified GMP for Biological Products

Certified in GMP for Biological Products

IGMPI is offering an opportunity to get certified and become a certified GMPfor Biological ProductsProfessional. This certification is meant for experienced professionals who are already a part of any manufacturing setup and are aware of the GMP regulations applicable in their line of work. To enable the participant, clear the qualifying exam for obtaining the certification, the institute will be offering proper training materials which will be provided without any extra cost save for the cost for applying for the Certification Examination.

The development of new biopharmaceuticals and biotechnology products promises to bring about a revolution in global healthcare. The manufacture and control of such products brings with it special concerns and challenges. This focuses on good manufacturing practices of biological products which assures product quality and patient safety. The case study based approach in certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified professional in the domain. This certification is also beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced certification having rigorous case studies based methodology throughout the duration.

The case study based approach in the training provided for the certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified GMP for Biological products professional in the domain. This certification is also beneficial for professionals from different streams to help them intensify their knowledge. An advanced training having rigorous case studies based methodology will be imparted to all participants for preparing for the Certifying Examination.

Certified Study Resources

Module 1 : Concept of Biologics

Module 2 : How do Drugs and Biologics Differ?

Module 3 : Manufacturing Process for Biologics

Module 4 : Introduction: Good Manufacturing Practices and its Regulations

Module 5 : GMP for Biological Products (US FDA Perspective)

Module 6 : Good Documentation Practices: Integral Part of GMP

Module 7 : GMP for Biological Products

Module 8 : GMP for Biological Products in Indian Perspective

Module 9 : WHO GMP Guidelines for Biologics

Module 10 : Qualification and Validation

Module 11 : Quality Audits and Inspections

Module 12 : Handling Complaints and Recalls

Module 13 : Data Integrity and Case Studies analysis

Eligibility

Any Graduate/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

Minimum duration to complete this programme is 3 months and maximum is 6 months.

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

– Assignments for all the programme modules for continuous evaluation and guidance.
– Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
– Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
– All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
– Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
– At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
– All learning and training delivery initiatives shall be conducted in English.

Assessment & Certification

All the participants are expected to appear for online assessment. After successful completion the participants will be certified as professional in GMP for Biological Products by IGMPI. For all the above mentioned elaborate study resources, Assessment test papers and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well. The certification will be awarded after the required levels of knowledge, skills, professionalism and attitude are assessed through the IGMPI assessment process.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare like Lupin, Zydus Cadila, Intas Pharmaceutical, Ajanta Pharma Limited, The Himalaya Drug Company, Medanta Pharma, AragenLifescience, Glaxo Smith Kline Consumer Healthcare, Bioclinica, Titan Laboratories Pvt. Ltd., Dr, Reddy’s Laboratories Limited, Wockhardt, Panacea Biotec Limited etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future Prospects

Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare industry to Conduct Lead analytical product development & characterization of Recombinant Proteins (Monoclonal Antibodies-Mabs, Biosimilars), Review of documents, CTD, Master Validation Plan, Qualification Plan Lead etc. for pipeline Biosimilar for US ,EU markets, recording production and test data for evaluation by research personnel and Examine animals and specimens to detect the presence of disease or other problems. Certified Professional in GMP for Blood and Blood Components provides the required knowledge to get selected as Quality Assurance Manager, Regulatory Affairs Manager, Research Chemist, GMP Manager etc.

View Prospectus

Programme Fee Details

How to apply

For further enquiries, write to or call us on::
info@igmpi.ac.in / 18001031071 (Toll Free), Phone: +91 11 26512850