Good Manufacturing Practices (GMP) as applied to Investigational Medicinal Products (IMP)
Target Sectors
IMP Pharmaceutical ManufacturersContract Laboratories testing IMPs
Any company considering obtaining an IMB Manufacturing License to Import IMPs
Clinical Research Organisations
Duration
1 DayTarget Audience
Production staff at all levelsClinical Investigators
Quality Control and Quality Assurance staff at all levels
Regulatory and Compliance staff at all levels
Topics Include
EU Clinical Trial Directive and May 1, 2004Current Influences on global direction of GMP for IMPs
GMP for IMPs Per EU Rules Volume IV
The Irish Medicines Board and FDA perspective on GMP for IMPs
Hot Topics in GMP for IMPs
Course Format
The course consists of formal content presentation interspersed with content quiz sessions, the presenters style involves intensive audience participation. The course may be modified to run in house in client companies.About the Course Leader
Aidan Madden is General Manager of FivePharma Scientific Ltd, an Irish company offering tailored training courses to the Pharmaceutical and Allied Sectors. In addition Five Pharma can provide Qualified Person services and assists in Quality Systems Development as well as offering contract auditing services. Aidan Madden has many years experience working for multinational pharma and biologics companies in various Quality Roles. For further information please see attached leaflet.
Training Courses
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- Good Manufacturing Practices (GMP) to (IMP)
- Internal Auditing and Self Inspection
- Good Distribution Practices (GDP)
- UK Good Distribution Practices (UK GDP)
- The History of Drug Development
- Supply Chain Integrity and Tamper Proofing
- Business Writing Skills
- Interview Skills
- Managing Difficult People
- Performance Coaching Skills
- Training for Managing People
- Understanding Team working
- Time Management
- Good Documentation Practice
- Writing Effective Standard Operating Procedures and Process Documents
- Upskilling
