FDA insists compliance of cGMP while manufacturing of pharmaceuticals. Also, compliance of cGMP ensures satisfaction to stakeholders (patients). It has been a mandatory requirement that persons involved in manufacturing of pharmaceuticals should be adequately trained for cGMP, as compliance of cGMP is a responsibility of all the persons involved in manufacturing.
• Workshop Contents::-
- What is GMP & cGMP?
- Purpose & Scope of cGMP
- Tools to guide cGMP
- Responsibility of Administration , Ware- house , Production , Engineering , Quality Control , Quality Assurance to follow cGMP
- Qualification of equipment & instruments
- Calibration
- Validation overview
- Documents & Records
- House- keeping
- SOPs
- Benefits of implementation of cGMP
• Methodology:-
- Activities
- Videos
- Case Studies
• Facilitator: Dr. Milind Pathak:-
Dr. Milind has rich experience of more than 3 decades to his credit at various levels in reputed pharmaceutical organizations in Quality, Manufacturing and Regulatory compliance during his professional assignment. He successfully faced several regulatory audits during this tenure.
Presently, representing Quality Circle Forum of India as an expert to deliver training programs on various topics on Pharmaceutical Quality Systems.
He has conducted more than 350 training programs covering around 3000 professionals at different locations and deeply involved with around 50 organizations to train their professionals.
• Expert Trainer :-
Dr. Milind Pathak
(Joint Secretary & Principal Faculty, QCFI Ankleshwar Chapter).
• Day & Date :
Wednesday, 25 th November, 2019.
• Time :
9:00 A.M. To 5:00 P.M.
• Participation Fees:
Members : Rs.1600/ + 18% GST
Non-Members : Rs. 1900/ + 18% GST
• Venue :
BDMA Conference Hall,
2nd Floor, 7x-The Business Hub,
Old N.H. 08, Bharuch.
• For Registration Contact:
7624004031 / 02642-226619
[email protected] / [email protected]