Online Training for

Combination Product

Learn how cGMP requirements apply to biologic products in Pharmaceutical, Medical Device, and Biologic product.

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TRAINING WHITE PAPERS
Coaching to Improve Training Results	Do You Need a Trainer or a Training Consultant
Benefits of e-Learning	How to Source Training
The Advantages of Certifying In-House Trainers	Is our Subject Matter Expert (SME) the right choice to become our in-house trainer?
The Unlocked Potential of your Training Resources	cGMP Annual Training
To Train or Not to Train?	In a Regulatory Inspection, How do you Justify Training?
Qualification of Key Roles	Implementing a Competency Based Training System
The Importance of Role Based Training

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Combination Product

This web based training module focuses on the Combination products Guidance document issued by the Food and Drug Administration (FDA) January 2017 for Current Good Manufacturing Practice requirements for Combination Products. This hour long training is a high-level overview of the regulations and how they apply to Combination products from the Pharmaceutical, Medical Device and Biologic Industries. This course provides a clear regulatory understanding of the obligations manufacturers of Combination Products have.

Training is done through ePath, the PathWise online learning management system. ePath is targeted knowledge based learning done on the web. 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.

Combination Product training is appropriate for all employees involved in the support of their industries connection to developing combination products.

The Combination Product 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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