Search Trainings
Advertising and Promotional material compliance and review process
The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, stra ...
- Basic & Intermediate
- 90 Mins
- Peggy J.Berry
- Aug 21, 2019
GDPR & California Consumer Privacy Act
During this session we will discuss GDPR & California Consumer Privacy Act (release 2020). Why it’s important and also, why are stricter rules and regulations being created. Is it with the public in mind?
- Basic & Intermediate
- 60 Mins
- Justin Muscolin
- Aug 27, 2019
Cannabinoids As Drugs – Latest Updates
This webinar will discuss the current status of cannabinoids as medical products in the United States. The focus will be on what we can learn from the FDA approval of Epidolex (Cannabidiol) oral solution 100 mg/mL. How to obtain research information will be pr ...
- Basic & Intermediate
- 90 Mins
- Loren Gelber
- Sep 10, 2019
GMPs for Medicinal Cannabis Growers and Processors
The medical marijuana industry is in its infancy in the United States. A large number of individual states have legalized medical marijuana to varying levels of control and regulation. Medical marijuana is illegal on a US Federal level but all predictions are ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- Sep 13, 2019
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
- Sep 24, 2019
Medical Device Software Verification and Validation
This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.
- Basic & Intermediate
- 60 Mins
- Nancy Knettell
- Oct 04, 2019
EN/IEC 62304 - Is your Medical Device Software Out of Compliance?
This course is essential for Medical Device and IVD companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for ...
- Basic & Intermediate
- 60 Mins
- Nancy Knettell
- Nov 06, 2019
Preparing a 21 CFR Part 11 QMS Software Validation Protocol
Review a company's software and Part 11 Verification and Validation System for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance, and how it addresses Part 11. Evaluating its elements against ISO 14971 and ICH Q9 for hazard analysi ...
- Intermediate
- 90 Mins
- John E. Lincoln
EN/IEC 62304 - Is your Medical Device Software Out of Compliance?
This course is essential for Medical Device and IVD companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for ...
- Basic & Advanced
- 60 Mins
- Nancy Knettell
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 ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo