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Understand the general requirements, licensing, and biologic standards for 21 CFR Parts 600, 601and 610.

Petri Dish


Biologics and biotechnology regulations are becoming increasingly rigid, and having the right support can make all the difference. This hour-long Biologics Training discusses a high-level understanding of the regulations for the Biologics industry, using web based training (WBT). The course provides a breakdown of the FDA requirements in 21 CFR 600601, and 610. These FDA requirements are important and support your business and compliance drivers.  Major topic areas covered are general requirements, licensing, and biologics standards.  (This course does not include blood and blood products, 21 CFR part 606.)

Training is done through epath, the PathWise online learning management system. ePath is on-Demand e-learning for targeted knowledge-based learning. Our knowledge-based Web Based Training focuses on terms, definitions, regulations and expectations.

Our Biologics Web Based Training covers the following areas:

  • 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

These are the benefits of the Biologics web based training:

    • Optimize productivity and training time.
    • Flexible mobile learning using a desktop, laptop, tablet or mobile device.
    • Fulfill new hire and annual FDA training requirements.

This training is appropriate for all employees involved in the manufacture or support of the Biologics industry.

The Biologics online training module is worth 0.1 CEU credits.

PathWise is accredited by the International Association for Continuing Education and Training (IACET).  PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.

Learners must complete the following in order to earn CEU credit:

  • Verify your electronic signature
  • Complete the full course module on ePath
  • Complete the full instruction module
  • Complete the post course assessment on ePath with an 80% score or better (learner will be given 2 opportunities to take the assessment).

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