Search Trainings
21 CFR Part 11 (Electronic Records and Signatures) Compliance for Computer Systems Regulated by FDA
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
- Jul 09, 2020
ETHICS: BEST PRACTICES AND DECISION MAKING
This webcast is intended to discuss with professionals the importance of ethics in all our business relationships and in the performance of our duties. We will look at what “ethics” is and discuss processes, procedures, and controls we can use to maintain our ...
- Basic & Advanced
- 60 Mins
- Candace Leuck
- Jul 17, 2020
European Union Device Regulation (EU MDR)
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The ...
- Intermediate
- 60 Mins
- Edwin Waldbusse
- Jul 22, 2020
Ten Keys for Maximizing the Benefits of your Measurement Systems Assessments
The effective use of data to drive decision making requires adequate measurement systems. When interpreting data or the results of data analysis, we assume that data or results represent the process. However, excessive measurement error may result in inappropr ...
- Intermediate
- 90 Mins
- Steven Wachs
- Aug 10, 2020
Process Capability Assessment for Normal and Non-Normal Data
Companies must assure that their processes are capable of producing products and services that consistently meet customer specifications. This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for ...
- Intermediate
- 75 Mins
- Steven Wachs
- Aug 18, 2020
Technical Writing: A Detailed Process
Provides step-by-step instructions to produce excellent written presentations Learn how to balance between being precise enough to cover the subject matter yet general enough to apply to other locations and/or projects Learn how to deal with reviewers and ...
- Advanced
- 60 Mins
- Robert Peoples
Ten Keys for Maximizing the Benefits of your SPC Program
Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to “listen” to their processes so that potentially harmful changes will be quickly detected and rectified. However, not all SPC pro ...
- Intermediate
- 90 Mins
- Steven Wachs
Fundamentals of Fraud
Fraud is a constant in our lives and must be recognized and eliminated wherever possible.In business, non profit, and business environments it is the responsibility of everyone within an organization to be able to identify fraud. If we do not perform due dilig ...
- Basic & Intermediate
- 90 Mins
- Candace Leuck
Work Has Been Suspended – What Damages Can A Contractor Recover
When an owner issues suspends work directive is the contractor entitled to recover delay and delay damages.? This session examines what damages are typically owed when work is suspended and some limitations of suspension damages. Five court cases setting forth ...
- Basic & Intermediate
- 90 Mins
- James G. Zack
Developing an Environmental Monitoring Program Satisfying FDA’s Listeria Monocytogenes Guidance
FSMA (Food Safety Modernization Act) requires organizations to assess risks, enact Preventative Controls to mitigate these risks and minimize Food Safety Hazards for consumers. With few exceptions, this generally requires rigorous programs such as an Environme ...
- Basic & Intermediate
- 60 Mins
- Gina Reo