This hour-long CBT discusses a high-level understanding of the regulations for the Biologics industry. The FDA requirements are important and support your business and compliance drivers. The course provides a breakdown of the FDA requirements in 21 CFR parts 600, 601, and 610. Major topic areas covered are general requirements, licensing, and biologics standards. (This course does not include blood and blood products.) Biologics is taught as an e-learning course taken through our ePath learning system on a desktop, phone, or tablet.Understand How/Why/Who the Biologic Regulations Apply to
Learning Objectives:
- Understand how/why/who the Biologic regulations apply to
- Define an understand key terms related to Biologics
- Define the licensing steps in the Biologic Industry
- Determine and apply relevant information to the General Biologic standards
Benefits:
- Optimize productivity and training time
- Flexible mobile learning using a desktop, laptop, tablet or mobile device
- Fulfill new hire and annual FDA training requirements
Biologic training is appropriate for all employees involved in the manufacture or support of Biologics industry.
