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21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Feb 01, 2023
Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud-hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulat ...
- Basic & Intermediate
- 90 Mins
- David Nettleton
- Feb 24, 2023
The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate
- 120 Mins
- David Nettleton
- Mar 23, 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
Supervising a Human Error Free Environment: You Can Do a Lot More Than You Think
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
Medical Device Cyber security and FDA Compliance
This webinar will focus on the 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 coul ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
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