Courses, Quality Management

Cognicert Pharmaceutical Good Manufacturing Professional

Become acquainted with the best practices for implementing Good Manufacturing Practices — Guidelines for the application of Good Manufacturing Practices (GMP) in Pharmaceutical Manufacturing.

Summary

“Pharmaceutical Good Manufacturing Practice gives guidelines for the production, control, storage and shipment of cosmetic products”. It provides a comprehensive approach for a quality management system for those engaged in the manufacturing, packaging, testing, storage, and transportation of pharmaceutical finished products. Pharmaceutical Good Manufacturing Practice has its basis in other quality management systems, ensuring a smooth integration with those quality management systems. This course enables participants to learn about the best practices for implementing and managing a Good Manufacturing Practices (GMP) for pharmaceutical industry. The participant will learn the different components of a GMP, including the GMP quality manual, required procedures, records, cleaning and contamination control, internal audit and continual improvement.

 

Who should attend?

  • Members of a Quality team
  • Professionals wanting to gain a comprehensive knowledge of the main processes of a Pharmaceutical Good Manufacturing Practices (PGMP)
  • Staff involved in the implementation of the PGMP
  • Staff involved in operations related to a PGMP
  • Auditors

Learning objectives

  • To Understand the implementation of a Pharmaceutical Good Manufacturing Practice
  • To Understand the relationship between a Pharmaceutical Good Manufacturing Practice and compliance with the requirements of different stakeholders of the organization
  • To Know the concepts, approaches, standards, methods and techniques allowing to effectively manage a Pharmaceutical Good Manufacturing Practice
  • To acquire the necessary knowledge to contribute in implementing a Pharmaceutical Good Manufacturing Practices (PGMP).

 

Course Agenda

First Day

Section 1 – Introduction to the Regulations

  • What are the GMPs
  • Intro to the FDA
  • Intro to the FD & C

Section 2 – Other Regulatory Agencies

  • EU and other regulations
  • Importance to our manufacturing

Section 3 – Organization and Personnel Roles and Responsibilities

  • Department Roles/Functions
  • Interactions
  • Training
  • Change Control

Second Day

Section 4 – Facilities & Equipment

  • Types of Facilities – Solid Dose, Aseptic, Biologic, API
  • Facilities and Equipment – the role they play
  • Flows – Material, Air, Personnel
  • Lighting, Plumbing, & Containment/Contamination

Section 5 – Vendors and Materials Control

  • Classification of materials according to function
  • Material specifications
  • Vendor Auditing – qualifying, and controlling suppliers and contractors
  • Control of incoming materials
  • Container Closure and other GMP functions
  • What the regulations require for reduced testing

Section 6- Process Control: “Master Batch Records and Validation”

  • The Validation Master Plan
  • Review and Approval of Master Records
  • Converting the Master Record to a Batch or History Record
  • Predicate rules and Part 11 – What are they really
  • Another new paradigm-Process Analytical Technology (PAT)

Section 7 – Packaging and Labeling

  • Why is packaging and labeling is so important?
  • Controlling Labels and other Printed Materials
  • Examining and storing Packaging & Labeling Materials
  • Controlling labeling operations

Section 8 – Validation (applying CGMPs)

  • Qualification v. Validation
  • Protocol Development
  • Types of Validation
  • Executions
  • Final Reports

Third Day

Section 9 – Laboratory Controls

  • Sampling
  • Analytical methods-Scientific Basis, Approval, & Validation
  • Pharmacopeias
  • Methods Validation Requirements
  • Equipment Qualification Requirements
  • Controlling Reagents & Reference Standards
  • Laboratory Data-Notebooks, LIMS, & Disks
  • Equipment Controls
  • Using a Contract Laboratory

Section 10 – Product Release and Distribution

  • QA Responsibilities in Product Release
  • Why perform testing on finished products?
  • Batch Record Review
  • Recalls

Section 11 – Records – Reports – Investigations

  • Storing Documents and Retains
  • When Things Go Wrong
  • Getting to the Root Cause

Section 12 – Quality Reviews and Assessments

  • PGMP Assessment Fundamentals
  • Principles of audit and Challenges of PGMP Assessment
  • Internal Assessments
  • Management Reviews
  • Stages of external Assessments
  • Creating a Corrective Action Plan
  • The Root Cause Analysis Process
  • Corrective and Preventive Actions
  • External audit follow -up

 

Duration: 5 days

Training Methodologies

  • Case Study
  • Individual Exercises
  • Role Play
  • Group Exercises
  • Group Presentation
  • Examination

Assessment and Qualification
Learning is assessed through:

  • 3 hours open examination. Passing the exams qualifies the candidate for Cognicert Pharmaceutical GMP Professional (CPD Certificate)
  • Practical experience of 25 days with activity log qualifies participants for our Cognicert Pharmaceutical GMP Professional (Implementer Category) I.D Card and Certificate
  • Practical experience of 50 days with activity log qualifies participants for Cognicert Pharmaceutical GMP Professional (Lead Implementer Category) I.D Card and Certificate

Self-Study Material, Exam and Certification 

Online Training, Material, Exam and Certification 

Classroom Training Location Here (Fee to be decided by delivery partners)

 

                 EXAM APPLICATION DEADLINE
   
February 27 January 22, 2022
March 24 February 22, 2022
April 21 March 22, 2022
May 18 April 22, 2022
June 22 May 24, 2022
July 27 June 22, 2022
Aug 24 July 22, 2022
September 21 August 24, 2022
October 19 September 15, 2022
November  23 October 13, 2022
December 18 November 11, 2022

Cancellation: 3 weeks before examination attract 100% refund. 0% refund after.