The GMP Fast Track Freshers Training Programme is a useful training course for individuals either new to a healthcare manufacturing company or moving departments, to learn and understand more about Good Manufacturing Practice (GMP) and its application.
The first day of the programme is the Introducing GMP Training (1 Day) Course, building an understanding of GMP and its application.
The second day progresses to investigate electronic records and signature requirements for America and the EU. Important consideration is given in the use of best practice SOPs, and corresponding training and evaluation. An overview of the validation process and how it is implemented is described and explained.
The course enables learners to investigate the regulatory drive for implementing risk management (review of Q9 Guidance), including the FMEA risk assessment method and the importance of change control including related issues. Learners also apply their learning by reviewing real case studies where GMP non-compliance could occur, determining potential solutions to such situations.
What is GMP?
The history behind GMP
Why is there a need for GMP?
Quality assurance links to GLP, GCP, GDP, and GAMP®
GMP and its link with Quality Assurance and Quality Control
The importance of the quality unit
Change control and its impact
The new focus of applying risk assessment
What are the relevant regulations?
The Orange Guide and European Directives
Change control and its impact
The Code of Federal Regulations
Who the regulatory agencies are, how they audit and enforce the regulations, including legal requirements
Types of audit including the FDA systems approach
Current hot topics in the regulatory world
Investigate the 4 Ps: People; Procedures and documentation; Production areas and equipment; Products and components
People - Adequacy, experience, training and the role of the Qualified / Responsible Person
Organisational structure and adequacy
The importance of training, experience and qualification as viewed by the regulators
Personal hygiene requirements
Procedures and documentation - from the completion of SOPs to in-process controls
Sufficient and efficient use of SOPs
Packaging instructions, batch manufacturing records, in-process controls and associated documents
Warehouse and logistics; status labelling, and FIFO
Associated errors with documentation
Production areas and equipment - premises, layouts and considerations
The importance of cleanliness; clean rooms, sterile operations and gowning operations (including links to micro-biological and cross contamination)
An overview of basic microbiology and GMP
Layout of facilities and equipment
Packaging and manufacturing equipment; design, validation, line clearance, components and materials, label control and reconciliation
Products and components
Incoming, handling, storage, packaging, labelling and non-conforming products
Threat of mix-up and contamination
Importance of change control and purchasing
Printing on packaging
Product security attention through on-line controls
Process validation and change control; life cycle concepts
Understand good documentation practices
Basic terms and definitions relating to manufacturing and packaging operations
Types of documents; records and instructions
Legal requirements; retention period and completion
Lifecycle of an SOP
How to complete a document correctly
Electronic records and signatures and 21 CFR Part 11
The importance of Standard Operating Procedures (SOPs)
Managing SOPs effectively
Everyday use of SOPs
What makes a good SOP?
Training requirements and best practices
Explore errors in documentation using examples and case studies
Common everyday occurrences which affect businesses and customers
Common highlighted FDA warning examples
Investigate why healthcare manufacturing companies have to carry out validation
History of validation and links to GMP
What is validation and its purpose?
Understand the key stages of the validation model, terminology, and processes for new and other projects
What is GAMP®?
The principles of validation
European and USA regulations and validation, including 21 CFR Part 11 and Annex 11 and 14 (EU GMP Guidance)
What can go wrong in companies?
Investigate why Change Control is a vital ingredient of GMP for pharmaceutical and medical device manufacturers
Consider the consequences of non–compliance to GMP for patients through inadequate application of the Change Control process
Identify why Risk Management has become important in the regulatory world of healthcare manufacturing
Interpret the ICH Q9 guidance document, including common Risk Management terms used and how it can relate to being used in companies
Consider utilising a Failure Modes Effects Analysis (FMEA) method for applying Risk Management approach for change control activities
Solve problems for GMP improvements
Investigate several problem solving techniques to apply to a real scenario
Apply previous course learning to identify potential GMP violations and their consequences
Use case studies of possible real events in manufacturing plants
Team activities, analysing problems and identifying solutions
Review of recorded real events; FDA warning letters and latest topics
Use interactive case studies to analyse scenarios
Reflect that people are the biggest threat to GMP
Examine real reported incidents
Determine behaviours that improve GMP
Apply the FMEA risk assessment method to a potential new project
Relate to real work activities
Plan for workplace improvements
Action plan for applying learning