NOTE:  this is an example of the outline for a recently presented general orientation course......................

What are biologics? 

Why USDA not FDA:  How do these agencies differ in approach?

Laws/regs/guidance: How can I tell the difference?  Does it matter?

Label wording drives everything:  where does it come from?  

On time/Under budget:  What tools help ensure effective project management

Master Seed Principle

Master Seed/Master Cell Selection

Master Seed/Master Cell Testing

Adjuvants

Preservatives/Excipients

Challenge Model Selection

Test Method Development

Protocol Development: working effectively with your statistician (and USDA’s)

Study management

Data Analysis: working effectively with your statistician (and USDA’s), part II

Report Preparation

Gaining Timely Acceptance of Efficacy Claims

Common methods

Validation

Laying the Groundwork for Ongoing test validity

Pre-license safety and stability demonstration

Scale-up and Pre-License Serial Requirements

Plant Approval:  Issuance of the Establishment License

Product Approval:  Issuance of the Product License

Routine procedures for USDA review of serials for release

Post-license safety and stability monitoring

Post-license reporting requirements

How do the best in-house change management programs help maintain compliance during times of growth and change