About this program
Current Good Manufacturing Practices (cGMP) are an essential element in the certification of any pharmaceutical plant by national or international regulatory bodies. cGMP is not only the day-to-day routine of any standardized manufacturing plant, but it is a vital sign of growth, improvement, and meeting customers’ expectations first.
Pharmaceutical good manufacturing practices is of pivotal importance, and it’s the integral part of health care system and ultimately affects our community health and Country’s economy. This certificate program is designed on the guidelines fetched from the Body of Knowledge (BOK) of ASQ. This certificate diploma program covers the complete supply chain of pharmaceutical manufacturing operations, including the Business and marketing perspectives as well.
OBJECTIVES
- To create an interactive demonstration of practical shopfloor constraints for the participants and come up with a solution as per current GMP guidelines.
- To enable the participants for real-time problem solving and decision making.
- To enhance the awareness and understanding regarding advanced concepts and techniques in pharmaceutical/nutraceutical/biotech businesses.
PROGRAM CONTENTS
- Structure and design of a pharmaceutical plant.
- Pharmaceutical product quality.
- Quality management system.
- Performance management and employed tools & techniques.
- Quality as a core business.
- Regulatory governance.
- Dossier submission—e-submission.
- Serialization, digitization, and pharmacovigilance.
- Risk management through the product supply chain.
- Project management as a tool for pharmaceutical business improvement.
- Laboratory control and compendial compliance.
- Work optimization in labs.
- ISO 17025
- Production processes: equipment design, environmental control, transportation, and distribution.
- Post-market complaints, investigations & CAPA.
- Incident reporting and recalls.
- Documentation design and control.
- Data integrity.
- Qualification & Validation.
- Change control.
- CI
- Pharmaceutical engineering.
- Pharma 4.0 industry
METHODOLOGY
Interactive class sessions, group discussions, current GMP/GVP (activities/gamification), videos, case studies, real-time projects/theses, and the appearance of guest speakers.
PARTICIPANT PROFILE
This program hisdesigned to cater thto e learning needs of professionals in their mid-careers. Professionals from pharmaceuticals, nutraceuticals, biotech, and allied manufacturing industries (e.g., packaging material manufacturers or API manufacturers).
PROGRAM DURATION/DAYS
The program is of four-month duration. Classes will be on Sunday froms, 10:00 am to 04:00 pm.
LEARNING INVESTMENT
The fee for the entire program is Rs. 70,000/- (SST will be applicable on all training programs held in Sindh).
For details and registration, please contact the Diploma Office,
Diploma Office, Management Shahrah-e-Iran, Clifton, Karachi
Voice Dir: (+9221) 99251 669 EPABX: (+9221) 9925 1711-14 Fax: (+9221) 9925 1715-16
Cell: 03432499855, 03337326730, 03122464635, 03333028660
E-mail: diplomakhi@pim.com.pk