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Test Method Validation to Verify your Device Performance
This webinar will help you have an understanding of Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements, and how to perform successful TMV to ensure your inspection of verification is effectiv ...
- Basic & Intermediate
- 60 Mins
- José Mora
- Jul 08, 2022
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, tem ...
- Basic & Intermediate
- 60 Mins
- Roger Cowan
- Jul 12, 2022
How to comply with the FDA’s Quality System Regulation 21CFR Part 820
21 CFR Part 820, known as the Quality System Regulation QSR outlines the Current Good Manufacturing Practice (cGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, in ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- Jul 12, 2022
Pharmaceutical Compressed Air:Quality GMP Standards and Requirements
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system are essential for maintaining a quali ...
- Intermediate
- 60 Mins
- Roger Cowan
- Jul 22, 2022
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most im ...
- Intermediate
- 60 Mins
- Roger Cowan
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
- Intermediate
- 90 Mins
- Ginette Collazo
How to Write SOP's for Human Error Reduction
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Proced ...
- Basic & Advanced
- 90 Mins
- Ginette Collazo
Reducing Memory and Attention Failures/Errors: Cognitive Load Assessment
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage and usu ...
- Intermediate
- 90 Mins
- Ginette Collazo
Human Error Reduction In GMP Manufacturing/Floor
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From p ...
- Intermediate
- 90 Mins
- Ginette Collazo
CPT 101
So much a part of coding from CPT is understanding the parenthetical that the AMA(American Medical Association) has added in the manual as guidelines in choosing the appropriate CPT code for a procedure or service. There are tricks of the trade and coding con ...
- Basic & Intermediate
- 60 Mins
- Lynn Anderanin