ComplianceOnline

This webinar on addressing fungal and bacterial spore outbreaks will discuss case studies on excursion investigations and show how facility design, personnel practices and cleaning and disinfection effect excursion investigations.

This webinar will help you understand the new FDA regulations directed to the place of New Dietary Ingredients in the FDA regulatory Scheme.

This webinar will discuss the details of specific excursion investigation for outbreaks of molds, vegetative bacteria, and Bacillus.

This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements.

This training on Forced Degradation study on a Protein Therapeutic will discuss on the Forced Degradation Studies required for Well Characterized Protein.

This 90-minute training will discuss the FDA's QSR requirements for a Device Master Record (DMR) and how you can use it to build your Device History Record (DHR).

This webinar will cover the basics of design controls for medical devices, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution.

This Process Validation training will look at the underlying statistical concepts to perform an effective process validation.

This 3-hr training will discuss medical device regulations and law in the US, Europe and Canada.

This webinar will review the typical non-conformances experienced in the (Medical Device) sterilization process and the course of action that should be taken by the manufacturer or contract sterilizer.