Search Trainings
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Nov 29, 2022
The Transfer of Validated Methods
This webinar will discuss the best practices for the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Dec 05, 2022
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis widely used to determine purity, impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Dec 19, 2022
How to Deal with Bad Results Under GLP
Assessment of the cause for non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts a ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Jan 04, 2023
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof t ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Jan 18, 2023
Project Management for Non-Project Managers – Forming, developing, and managing your project team
The subject of this webinar is building the project team. The key to achieving success with your project is the people you assign to it, how well you develop the team, and sustaining team members’ ongoing commitment to the successful completion of the project ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
Project Management for Non-Project Managers – Determining the work that needs to be done
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages. Decomposing a task is not a trivial or intuitive process. It is something that must be explained and p ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof t ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
Project Management for Non-Project Managers,How to Communicate Project Actions and Progress, Effective Project review Meetings
This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that ca ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
Basic Issues of Method Validation Compliance under Good Laboratory Practices
Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees the validity of results. If you work in pharmaceuticals, chemicals, petrochemicals, and environmental ...
- Basic & Intermediate
- 60 Mins
- John Fetzer