Good Manufacturing Practices (GMP) compliance has been a burning issue in Pharmaceutical industry. Pakistan Pharmaceuticals are striving to improve GMP complaint status, increase productivity levels and become highly competitive in the world market. Skills and knowledge & Developments of employees are major challenges in the Pharmaceutical industry of Pakistan. To respond to the need for adequate quality assurance of pharmaceuticals, PIQC is offering a pharmaceutical GMP Professional Course. The course is in line with ASQ certification model. It is based on the BOK (body of Knowledge) Covers compliance with good manufacturing practices (GMP’s), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics and dietary supplements (alternatively called nutraceuticals ) where regulated as drug products, as well as their component raw material (including active pharmaceutical ingredients (APIs) and excipients), and packing and labeling operations.

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Intended Learning Outcomes

  • A knowledge of “how things work” and how they impact the quality of product
  • An appreciation of the regulated and compliant pharmaceutical environment
  • It helps to advance your career and boosts organization’s bottom line through your mastery of quality skills.

Admissions

There is no minimum education or work experience requirements that specifically need to be fulfilled in order to get admission in CPGMPP course; however, a minimum of two years experience in the relevant  field is recommended.

Award of Certification

Qualified participants will be awarded a Certificate upon completion of course material, as well as qualifying the exam and the assigned project.

Course Contents

  1. Regulatory Agency Governance
  2. Quality Systems
  3. Laboratory Systems
  4. Infrastructure: Facilities, Utilities, Equipment
  5. Materials and Supply Chain Management
  6. Filling, Packaging, Labeling
  7. Product Development and Technology Transfer

Project

The participants are required to work on real life projects on selected topics and tools, preferably from the organizations, where they are working.  The projects will be of a practical nature and should be completed within the stipulated time frames.  A project report will be submitted in accordance with the laid down criteria, format and coverage

Faculty

The faculty is derived from a pool of qualified practitioners and academicians with sound track record and expertise in the field

Course Material

Course material, class notes and slides will be provided by trainers in hard form.

Teaching Strategies

This is a professional course and will involve a number of higher level teaching methodologies.  The course is spread over three months to allow inter-session study.  In this respect participants will have to carry out timely study, investigations, and assignments to grip the subject. Discussions in the class are focused on the key points, create critical thinking, share experiences of fellow professionals and build professional maturity

Duration: 04 Months
Venue: Karachi.
Course Instructor: Qualified and Experienced Practitioners and Academicians

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