Professional Diploma in Pharmaceutical Current Goods Manufacturing Practices (cGMP) – Karachi

INTRODUCTION

Current good manufacturing practices (cGMP) is the absolute 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 customer’s expectations at 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 Bok (body of knowledge) 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 to 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 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 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 GMPIVITY (Activities/ Gamification), Videos, Case studies, real time projects/ thesis and appearance of guest speakers.

 PARTICIPANT PROFILE

This program has designed to cater the learning needs of professionals in their mid-careers. Professionals from pharmaceuticals, nutraceuticals, biotech and allied manufacturing industries (e.g. packing material manufacturer or API manufacturer).

PROGRAM DURATION/DAYS

The program is of four-month duration. Classes will be on Sunday (10:00am to 04:00 pm)

LEARNING INVESTMENT

The fee for the entire program is Rs. 56,000/- (SST will be applicable on all training programs held in Sindh).

For details and registration please contact the Diploma Office,

Diploma Office, Management House, Shahrah Iran, Clifton, Karachi
Voice Dir: (+9221) 99251 669 EPABX: (+9221) 9925 1711-14 Fax: (+9221) 9925 1715-16
Cell: 0333-3028660 & 0333-3347789

E-mail: diplomakhi@pim.com.pk  aleem@pim.com.pk