As well as establishing the key requirements of GMP, the course focuses on the application of GMP in the working environment.
With recently announced changes in the regulatory approach to GMP compliance, delegates will be introduced to a number of science-base risk management tools, techniques and methodologies.
- Introduction to GMP
- Managing Quality
- Regulatory Approach to Risk Management - current and future trends
- Documentation and Records
- Contamination Control
- Manufacturing and Packaging GMPs
- PAT & Process Control
- Internal and External Audit Programmes
Detailed course outline - Click here (open/close) »
Introduction to GMP
- Overview of the history and development of regulatory control
- Review major GMP regulatory bodies worldwide and the roles of ICH and PICS
- Describe how MHRA and FDA regulate Products and Manufacturers
Regulatory Approach to Risk Management - current and future trends
- Fundamental concepts of QA, GMP and QC
- Roles and responsibilities
- Critical QA and GMP systems:
- Design control and change control
- Non-conformance control
- Corrective and preventative action
- The role of people in the management of quality
- Science-based risk management (focusing on FDA's cGMPs for the 21 st Century)
- Process Analytical Technologies (PAT)
Risk management methodologies:
Documentation and Records
- Types of GMP documents that are part of a quality management system
- Essential GMP requirements for documents and records
- Examples of the different types of GMP documents
- Requirements for document and record control
- Describe the current GMP requirements for electronic records and signatures
Manufacturing and Packaging GMPs
- Understand the term "contamination" with respect to pharmaceutical products
- Investigate the main types of contamination and their sources:
- Cross contamination
- Foreign materials
- Implement procedures to reduce the risk of contamination
PAT & Process Control
- Critical GMP requirements for manufacturing control and packaging control
- Controlling pre-printed matter under GMP
- The importance of adulteration and misbranding
- Preparation and review of SOP's for control of packaging materials and line clearances
- The control of yield and reconciliation of all components that make up the final product
- GMP requirements for pharmaceutical sampling plans
- Understand what the PAT initiative is and how it can benefit the pharma industry
- State the difference between common cause and special cause variation
- Be familiar with the terms:
- normal distribution
- standard deviation
- process capability
- Be able to construct a ‘stem and leaf’ plot to determine the state of a process
Internal and External Audit Programmes
- The structure and mechanism of the auditing process
- Differences between systems and compliance audits
- Key steps in a GMP or quality audit
- Internal GMP audit programmes, SOPs and schedules
- How to prepare, manage and respond to GMP regulatory audits
- Reasons for validation and the development of validation and regulatory control
- Application of risk management methodologies to optimize validation activities
- The 'V' model life-cycle approach to validation documentation
- The difference between critical and non-critical items in terms of validation
- Regulatory and GMP validation guidance documents
- 21 CFR Part 11 and computer systems validation
The course consists of a lively mix of presentations, group exercises and discussions. At the end of the course, there will be a short quiz to test understanding. Copies (pdf) of all presentation slides and handouts will be provided.
A complimentary information pack containing course details and preparatory exercises will be sent to each delegate prior to the start of the course.
Out of Class Assignment
Delegates are offered the opportunity to complete a GMP assignment following completion of the course. This will be facilitated and supported remotely by SeerPharma's team of consultants and successful completion will be rewarded with additional certification.
There is no additional charge for this.
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »
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