- 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
- 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).
- What are the GMPs
- Intro to the FDA
- Intro to the FD & C
- EU and other regulations
- Importance to our manufacturing
- Department Roles/Functions
- Interactions
- Training
- Change Control
- Types of Facilities – Solid Dose, Aseptic, Biologic, API
- Facilities and Equipment – the role they play
- Flows – Material, Air, Personnel
- Lighting, Plumbing, & Containment/Contamination
- 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
- 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)
- Why is packaging and labeling is so important?
- Controlling Labels and other Printed Materials
- Examining and storing Packaging & Labeling Materials
- Controlling labeling operations
- Qualification v. Validation
- Protocol Development
- Types of Validation
- Executions
- Final Reports
- 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
- QA Responsibilities in Product Release
- Why perform testing on finished products?
- Batch Record Review
- Recalls
- Storing Documents and Retains
- When Things Go Wrong
- Getting to the Root Cause
- 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
- Case Study
- Individual Exercises
- Role Play
- Group Exercises
- Group Presentation
- Examination
- 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
| 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 |