Medical devices span the therapeutic spectrum, from the toothbrush to life-saving heart implants. Even in simple devices, complex engineering challenges can arise that must balance mechanical, biological, regulatory, and other factors.
Frequent training is necessary to stay current on the practical demands of adhering to medical device regulations and validation processes, and helps ensure your manufacturing process will produce devices that conform to the approved design characteristics.
FDA Case Scenarios
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading FDA Case Scenarios
Read MoreIntroduction to Product Claims Development and Support
Differentiating claims are often key to successful OTC and CPG products. Consumer awareness of products is based on these labels and advertising claims that need to be both consumer meaningful and grounded in adequate scientific support. Agencies like the US-FDA, the Federal Trade Commission (FTC), and even TV networks have established requirements and guidelines on… Continue reading Introduction to Product Claims Development and Support
Read MoreBasics of Electron Beam Sterilization Process Requirements
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483’s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Electron Beam Sterilization Process Requirements
Read MoreBasics of Gamma Radiation Sterilization Process Requirements
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Gamma Radiation Sterilization Process Requirements
Read MoreBasics of Ethylene Oxide Sterilization Process Requirements
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Ethylene Oxide Sterilization Process Requirements
Read MoreBasics of Vaporized Hydrogen Peroxide (VHP) Sterilization and Decontamination Practices
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Vaporized Hydrogen Peroxide (VHP) Sterilization and Decontamination Practices
Read MoreRequirements of Aseptic Processing and Filtration Sterilization
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Requirements of Aseptic Processing and Filtration Sterilization
Read MoreBasics of Sterilization by Heat
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Sterilization by Heat
Read MoreCleanroom, Microbiology and Sterility Assurance Practices for Sterilization Processes
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Cleanroom, Microbiology and Sterility Assurance Practices for Sterilization Processes
Read MoreCleanroom, Cleaning, Sanitization and Disinfection Practices
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Cleanroom, Cleaning, Sanitization and Disinfection Practices
Read More