The research, development, manufacturing, and regulatory approval of new biotechnology and biopharmaceutical products often presents novel challenges for which a background in conventional pharmaceuticals offers little guidance.
To bridge this gap between academic instruction and the real-world complexities of research, development, validation, regulations, processing, and manufacturing, we provide practical, specialized training by industry experts. With ever-changing scientific understanding and government regulations, it’s critical that you have the most current information possible – training with COBBLESTONE ensures you will.
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
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 MoreCombination Product Risk Management Principles: Part 1
Managing the complex lifecycle of combination products requires the efficient utilization of resources of a pharma/device company regardless if the company is vertically integrated, utilizes bth in-house and contract manufacturing, or is a truly virtual company. Part 1 of this will define and apply recognized risk management principles in the identification of required GMP’s and… Continue reading Combination Product Risk Management Principles: Part 1
Read MoreCombination Product Risk Management Principles: Part 2
Managing the complex lifecycle of combination products requires the efficient utilization of resources of a pharma/device company regardless if the company is vertically integrated, utilizes both in-house and contract manufacturing, or is a truly virtual company. Part 2 of this training course will define and apply recognized risk management principles in developing effective and compliant… Continue reading Combination Product Risk Management Principles: Part 2
Read MoreBasic 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
Read MoreIntroduction 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
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