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.
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 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 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 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 MoreThe Art and Science of Product Claims
Product Claims explain what a product does, how it works, and why consumers should believe your message and purchase your product. Not surprisingly, differentiating product claims are often key to successful over-the-counter (OTC) and consumer packaged goods (CPG) products. Successful products include label and advertising claims that are understandable and compelling to consumers AND supported… Continue reading The Art and Science of Product Claims
Read MoreCompetitive Intelligence in Product Development
Consider any successful product or service, and it is highly likely its benefits and differentiation were informed by competitive intelligence. Without it, the product or service may fail and soon disappear from the shelf. Competitive intelligence can literally make that much of a difference. This training course will introduce the discipline of competitive intelligence and… Continue reading Competitive Intelligence in Product Development
Read MoreGood Documentation Practices for Laboratory Records
In FDA’s Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93), it is stated The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Good documentation practices are expected… Continue reading Good Documentation Practices for Laboratory Records
Read MoreHandling OOS Test Results and Completing Robust Investigations
It was the Barr Decision in the early 1990s that first coined the term Out-of-Specification (OOS). Since that landmark case, pharmaceutical companies, both drug and biologicals, have had to perform adequate investigations whenever an OOS result was obtained through laboratory testing. In the nearly 30 years since then, FDA continues to cite companies for not… Continue reading Handling OOS Test Results and Completing Robust Investigations
Read MoreBasics of Microbiology
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 Microbiology
Read MoreRequirements for Aseptic Techniques and 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 483’s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Requirements for Aseptic Techniques and Practices
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