Tailoring Training Solutions to GMP Processes
Tailoring Training Solutions to GMP Processes
Today’s Objectives • Describe the characteristics of typical training problems in pharmaceutical
manufacturing with emphasis on training populations, technical topic areas, organizational maturity, and funding.
• Describe the characteristics of the available training solutions, including comparisons between Instructor-Led options, Computer-Based Training, commercial off-the-shelf training, and custom-developed training.
• Successfully match the available training solutions to the pharmaceutical manufacturing training problem for the greatest impact and highest return on the training dollar.
Characteristics of Training In Pharma GMP
• Populations can be large or small • Some potential for seasonal workers • Computing resources may be scarce • Need for certifications • Need for real-time Questions and Answers • Knowledge/Skills transfer requires demonstration
Training Populations
• Sites – relatively small • Corporate – may be quite
large • Functions – dependent on
site output • May be multinational • Educational levels may be highly variable
Technical Topic Areas
• Dependent on site output/product – Aseptic or Sterile
Manufacturing – Space Classification – Gloving/Gowning
requirements – Packaging process – Novel techniques
Organizational Maturity
Organization Size/Age • Start up • Small • Medium • Large
• Very Large
Formal Training Process? • SOPs/Ad Hoc • SOPs/Ad Hoc • SOPs/Ad Hoc • Formal Development and
Delivery Structure • Formal Development and
Delivery Structure
Funding
Organization Size/Age • Start up • Small • Medium • Large • Very Large
Annual Budget? • Probably not • Probably not • Maybe not • Almost certainly • Certainly
Characteristics of Training Types
• SOPs – Low Tech/Low Touch – Required for operation – Supports standard procedures – Read and Understand – Not really training – Effectiveness can be improved
through online testing
Characteristics of Training Types
• Instructor-Led Training – High “Touch” – Some message variability – Great for certified procedures – Well-informed instructor is assumed – Free flow of questions and answers – Expensive, and cost is distributed
across the life of the training program
Characteristics of Training Types
• Asynchronous Computer-Based Training (CBT/WBT)
– High “Tech” – Repeatable message/standard
work – Most effective in Blended
Solution – Expensive, but costs are
front loaded
Characteristics of Training Types
• Synchronous Computer-Based Training (Webinar)
– High “Tech” remote enabled – Some message variability – Well-informed instructor is
assumed – Free flow of Q&A – Expensive, and cost is
distributed across the life of the training program
Buy or Build?
• Commercial Off-The-Shelf (COTS) – General in nature – Typically not very interactive – 80/20 Rule Applies – Cost Effective?
• Application Dependent
Buy or Build?
• Custom Training – Can be specific in nature
• Novel procedures
– Can be very interactive – Cost Effective?
• Application Dependent
What’s Best for Your Training?
Novel techniques
Computer Applications
Project Management COTS
Classroom ILT SOP
Questions