| Course Title: |
GMP Fast Track Freshers Training |
| Course Duration: |
3 days |
| Course Aims: |
To provide a basic knowledge of the importance of following current Good Manufacturing Practice.
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| Course Content: |
- 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
- MHRA
- FDA
- Types of audit including the FDA systems approach
- Internal audits
- 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
- Document control
- 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
- Regulatory requirements
- 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
- SOP problems
- 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?
- Solve problems for GMP improvements
- Understand creative thinking techniques
- Select and apply problem solving techniques to a real scenario
- Apply previous course learning to
- Identify potential GMP violations and their consequences
- Use interactive video case studies of 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
- Relate to real work activities
- Plan for workplace improvements
- Action plan for applying learning
ISPE owns the GAMP® trademark http://www.ispe.org/ |
| Course Dates: |
GMP Fast Track Freshers Training, 20th - 22nd November 2007, London, £1099+VAT per learner (£1291.33 inc. VAT).
GMP Fast Track Freshers Training, 29th April 2008 - 1st May 2008, The Midlands, £1000+VAT per learner (£1175 inc.VAT).
GMP Fast Track Freshers Training, 10th - 12th June 2008, London, £1099+VAT per learner (£1291.33 inc. VAT).
GMP Fast Track Freshers Training, 9th - 11th September 2008, Cheshire, £1000+VAT per learner (£1175 inc.VAT).
GMP Fast Track Freshers Training, 2nd - 4th December 2008, Bristol, £1000+VAT per learner (£1175 inc. VAT).
GROUP BOOKING DISCOUNT - Book two place on an open course and receive the third place at half price.
Cost includes tuition, lunch and training materials. Download a printable version of the Booking Form and Terms and Conditions.
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| On-site Courses: |
This course can be delivered to a group of up to 12 delegates at your premises. Request a quote for an onsite course. |
| Further Details: |
Request more information on this training course.
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| Related Courses: |
GAMP® 4 Training
Understanding the Regulation 21 CFR Part 11 Training
Understanding Validation Training
Validation & Compliance Training Programme
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| Course Calendar: |
View Course Calendar
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