Good Documentation Practice
Target Sectors
Pharmaceutical ManufacturersPharmaceutical Suppliers and Contractors
Active Ingredient and Excipient Manufacturers
Contract Laboratories
Any company considering obtaining an IMB Manufacturing License
Duration
2 DayTarget Audience
Production staff at all levelsQuality Control and Quality Assurance staff at all levels
Regulatory and Compliance staff at all levels
Course Summary
In order to stay in business we must comply with our legal obligation. Regulatory auditors rely very heavily on what the documents tell them. If it isn't documented it has not been done. Documents provide the proof and help us stay in business.Aimed at technicians, managers and supervisors who are responsible for documentation writing, this two-day programme provides practical guidance on the structure and essential content of Policies and SOPs. It emphasises how to get the most from your documentation while remaining regulatory compliant, but writing documents that are user friendly and add value to the operation.
Participants learn how to prevent unnecessary documents being written as they employ good design practices and use principles of good technical writing. They understand the 'What', 'Who' and 'How' of writing and yet learn to keep it simple; in other words, drive out complexity.
About the Course Leader
Patrick Cassidy M.Ed., FIITD, is a freelance Training & Development consultant, with business and management experience gained from a wide variety of industries. He has a strong background in HRD management, being in the role since 1980. This includes four years of managing T & D with a large pharmaceutical manufacturing company, eight years in the automotive industry and five years in textile manufacturing. In addition to coursework designed to meet the needs of middle management business skills, he provides advice and direction on OD interventions affecting HRD. Patrick holds a masters degree in training & education and is a Fellow of the Irish Institute of Training & Development
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
