Approved training courses

Course description

Who will the course benefit?
This course is aimed at people who work in Quality Assurance, Quality Control and Production personnel who need a greater appreciation of GMP than is often offered via traditional in-house GMP awareness training courses. The course is aimed at team leader and junior management level and is used as a development course for people who are to be managers of the future. The course is ideal for people who are new to the pharmaceutical industry and are in a role where a very good working knowledge of GMP is essential.
Course Overview
This course is presented over 3 days and provides a real depth of information on the main aspects of pharmaceutical GMP. During the course the main GMP requirements for purchasing, goods-in, the warehouse, production, packaging, Quality Control and batch release are covered. In addition, the course also covers the main elements of the Quality Management System needed to provided medicines of the highest quality, including the requirements for documentation, training and system monitoring and review. The course is full of interactive exercises and workshops throughout the programme.

Day 1: The reasons for GMP and GMP in facility design

Why do we have GMP?
GMP – rules and guidelines
European Union (EU) GMP and the EU Guide to GMP
GMP in the United States
Other GMPs from around the world
Premises and facility design
Suitable premises and facility design
Heating, Ventilation and Air-Conditioning systems
Access, security and pest control
Equipment, maintenance and calibration
Validation, qualification and change control
Water Systems
Networking event (optional)

Day 2: GMP in practice – incoming materials to product release

Purchasing, incoming materials, suppliers and outsourced activities
GMP requirements for incoming materials
Supplier selection and control
Control of outsourced activities
The warehouse
Control of incoming materials
Storage of materials
Issue of materials to production
Control of rejected and returned materials
Manufacturing
Different types of dosage forms
Initial checks of the area, equipment and materials
Documentation and records
Reporting of problems
Cleaning of the equipment and area
Packaging
Packaging equipment design and facility layout
Control of materials and product
Overprinting of artwork
Quality Control
Good Control Laboratory Practice
Test specifications and pharmacopoeias
Analytical method validation and method transfer
Recording of results and release of materials
Ongoing stability storage and testing
Evening 1-to-1 tutor meetings (optional)

Day 3: GMP and the Quality Management System

People and training
Organisation charts, job descriptions and training records
GMP, hygiene and job specific training
Training design and evaluation
Key personnel in GMP
The Heads of Production, QC and the Qualified Person
The role of Quality and Quality Assurance
The importance of Senior Management
Documentation, records and data integrity
Control and approval of documents and records
Data Integrity and regulatory concerns
The use of computer systems
Quality Risk Management
The need to make decisions based on risk
ICH Q9 and its requirements
Reactive and proactive risk assessments
Deviations, incidents and complaints
CAPA systems – good and bad points
Problem-solving and root-cause analysis
Dealing with complaints effectively
Specific GMP requirements for certain types of products
Sterile products manufacturing
Biological products
Advanced Therapy Medicinal Products
The Quality Management System
Batch review and release
Product Quality Review
Internal auditing
Management review
Continual improvement

Pre-requisites

On request from training provider

Additional info

For maximum interactivity and effectiveness, our class size is limited to either 10 delegates (live online interactive) or 12 delegates (classroom) with at least two tutors. The quality and effectiveness of our courses is unrivalled in the industry.

Training provider

Inspired Pharma Training

Email

info@inspiredpharma.com

Tel

+44 1635 866699