Internal Auditing and Self Inspection within the Pharmaceutical and Allied Sectors
Target Sectors
Pharmaceutical ManufacturersPharmaceutical Suppliers and Contractors
Active Ingredient and Excipient Manufacturers
Contract Laboratories
Any company considering obtaining an IMB Manufacturing License<
Duration
1 DayTarget Audience
Quality Control and Quality Assurance staff at all levelsRegulatory and Compliance staff at all levels
Production staff at all levels
Topics Include
Current Influences on global direction of auditing within the regulated sectorsThe influence of ISO on auditing
Auditing and the GMP EU Rules Volume IV
The Irish Medicines Board and FDA perspective on internal auditing and self inspection
Preparing a plant wide audit plan
Preparing for and executing an internal audit
Writing up an audit report
Hot Topics in auditing
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.
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
