Aseptic techniques are used to create compounded sterile products. In Microbiological term; Aseptic technique refers to prevention of microorganism contamination. This activity is most important for successfully manufacturing safe and sterile therapeutics. Continuous cleaning, meticulous processing, sterile apparel and use of specialized equipment are involved in these procedures. However, by overlooking these techniques by staff […]

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively […]

R&D activities are varied and many across the development process. When done correctly, these activities can be harnessed to provide valuable input to the risk analysis process, creating a seamless and robust risk analysis that is coherent with development and leads to stronger innovation. You will understand how to conduct research activities and harness useful […]

The U.S. FDA is well into their long-anticipated Unique Device Identification System. Its purpose is to “establish a system to adequately identify devices through distribution and use”. It requires the development of a unique device identifier (UDI) in plain text and machine readable formats, to be part of the labeling of every medical device. This […]

This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be […]

Bacterial Endotoxin Test (BET) is a vital safety requirement in the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and the medical device quality system regulations. A solid grasp of the concept of this critical release assay, its application and importance to the manufacture of cGMP product is paramount. This helps avoid costly errors, […]

Onboarding in a Pharmaceutical Good Manufacturing Practices (GMP) environment is a difficult task.  Compliance considerations, your quality culture, and work culture are all important points of focus.  Additionally, where does employee “onboarding” end and real “job training” start?  Your onboarding effort is critical in so many other ways too, as it represents your only opportunity […]

Officially there is no requirements as per the FDA and other regulatory bodies for “good documentation practices”, however, it is a “current” industry practice and if often reviewed and cited by auditors during audits. All legal and controlled documents are subject to the retention of information which should include the sign and dating of such […]

Despite best efforts, serious quality issues resulting in a recall can occur. Medical Device companies need to be prepared in advance to handle the difficult situation. This 6-hour virtual seminar will prepare you to understand the signals that trigger a need to recall, the investigation and other actions required, taking corrective and preventive action, and […]

This 3-Hour virtual seminar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. It will also address how human error occurs in the planning and execution stages of […]