Ensure Quality, Safety, and Excellence in Biomanufacturing.

This in-depth course covers key concepts and regulations of CGMP including clinical development through post-approval drug manufacturing.

This course covers lean manufacturing as a production process based on an ideology of maximizing productivity while simultaneously minimizing waste within a manufacturing operation.

This course provides training on the elements contained in the ISO 14001 specification for Environmental Management Systems, and the benefits of implementing these elements.

This course teaches a systematic approach to investigating quality issues, creating effective corrective action plans rooted in...

Describes regulatory requirements for a CAPA system in the biotech industry.

Strategies for implementing compliance with GDP, as well as standards and procedures for accurately completing Records required for current cGMP.

Explains requirements to establish and maintain regulatory compliance with 21 CFR Part 111 CGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.

Learn critical elements of the ISO 45001 Specification for Occupational Health and Safety Management Systems and strategies for their implementation.

Describes FDA’s regulatory controls for common marketing approval pathways for the classes of medical devices, and explains the Code of Federal Regulations that pertain to medical device approval in the U.S.

Covers covers the core principles of the 5S system and illustrates why using 5S is essential to a “Lean” initiative.