ComplianceOnline

This training will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-died products in vials, to foods.

This webinar will provide assistance to all regulated companies that utilize third party vendors, service suppliers that provide patient data, diagnostic/lab services or business partners involved in clinical trial or other regulated activities.

This training will outline practical steps to design medical devices that ensure patient safety. Hazard analysis techniques and safety design techniques for devices, including next-generation devices, will be reviewed.

This Medical device training will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with the new standards.

Learn the new GMP regulation 21 CFR 212, what are the compliance requirements for PET drug manufacturers, how to establish a quality system to ensure cGMP compliance.

This Part 11 Inspection training will answer all questions related to the new part 11 inspection program by FDA and FDA expectation of implementing part 11 requirements.

This session will survey the market affected by the proposed rule, and define the common components and capabilities of these systems.

This Sterility or Bioburden test Webinar/training will discuss on various items that should be investigated to determine the root cause and the follow up to the investigation.

In this medical device training on Importing and Exporting learn and understand the import and export process for unapproved and approved medical devices and the documentation process involved.

This sterilization validation process training webinar will review the FDA or ISO requirements for tests following validation and emphasis is placed on the appropriate tests for validation, the appropriate routine tests and the frequency of testing.