Subject: R&D

Basics 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

Basics 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

Requirements 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

Basics 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

Cleanroom, 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 483’s 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

Cleanroom, 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

Basic FDA GLP Training

Before any drug can be used on humans, it must first be proven to be safe through testing on animal models. The FDA Good Laboratory Practice (GLP) regulations were implemented in 1979 in response to the inadequate quality and scientific rigor of nonclinical (toxicology) studies. The FDA GLPs outline the requirements for conducting nonclinical studies… Continue reading Basic FDA GLP Training

Introduction to Lyophilization Technology

This course introduces you to the basics of lyophilization and why we lyophilize drug products. Typical approaches to developing a drug product formulation and lyophilization process development will be discussed. At the end of the course, you will be able to identify analytical techniques that are available to characterize drug products. The final goal of… Continue reading Introduction to Lyophilization Technology

Basics 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

Smarter Stabilization Strategies in Cosmetic Formulation

Stabilization mechanisms are a major area of importance in cosmetic product development. Emulsions can be particularly challenging to address. This accredited ON DEMAND webinar will enable the participant to understand how emulsions fall apart, how to fix them, and how to do a better job in emulsion formulation design. In addition, the participant will learn… Continue reading Smarter Stabilization Strategies in Cosmetic Formulation