Overview
This is a fast-moving, intensive training course aimed at Managers, Supervisors and Technical Staff working in the pharmaceutical industry.
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.
Day 1
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
Managing Quality
- 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
Regulatory Approach to Risk Management - current and future trends
- Science-based risk management (focusing on FDA's cGMPs for the 21 st Century)
- Process Analytical Technologies (PAT)
- Risk management methodologies:
Day 2
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
Contamination Control
- Understand the term "contamination" with respect to pharmaceutical products
- Investigate the main types of contamination and their sources:
- Cross contamination
- Microbial
- Chemical
- Foreign materials
- Implement procedures to reduce the risk of contamination
Manufacturing and Packaging GMPs
- 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
Day 3
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
Validation
- 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
Format
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 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.
To request further information on this course or to reserve a place (with no obligation) please contact us using the details below:
PO Box 3255,
Littlehampton,
BN17 9AD
Tel: 01903 730 622
e-mail: debra.stanfield@seerpharma.co.uk
