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