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 the development of a company philosophy and approa ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jan 19, 2021
Error-Free Spreadsheets
David Ringstrom, CPA, shares a variety of tricks and techniques you can employ to improve the integrity of your Excel spreadsheets as well as to audit the spreadsheets created by others. In this empowering session, he presents simple ways to prevent errors fro ...
- Intermediate
- 60 Mins
- David H. Ringst
- Jan 19, 2021
Remote Auditing During a Global Pandemic
Internal Audit and Supplier Audits are essential for medical device companies to self-identify and mitigate risks. The COVID19 pandemic has made this important task even more difficult due to travel restrictions. This webinar will provide insights into how to ...
- Basic & Intermediate
- 60 Mins
- Susanne Manz
- Jan 19, 2021
Leave in the Time of COVID: Managing Employee Leave Requests under FMLA, ADA
Even the simplest leave requests can be complex and nuanced, posing challenges to even the most seasoned Leave Administrators. The possibility of costly, drawn-out litigation, only adds to the stress and pressure. Add to that: most employees making leave reque ...
- Basic & Intermediate
- 60 Mins
- Janette Levey F
- Jan 19, 2021
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation This highly interactive training uses life examples and explores proven techniques for reducing costs, usually by two-thirds, as ...
- Basic & Intermediate
- 90 Mins
- David Nettleton
- Jan 19, 2021
Fundamentals of Construction Lending and Real Estate Credit Administration
Most bankers acknowledge that construction lending is riskier than other types of commercial lending: Repayment ability depends on successful completion of the construction before the project can generate cash flow from the sale of the finished property, fr ...
- Basic & Intermediate
- 60 Mins
- Dev Strischek
- Jan 19, 2021
A Verification and Validation Program to Meet US FDA and EU MDR / ISO Requirements
Review a company's Verification and Validation Program for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. Address the lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating it ...
- Intermediate
- 60 Mins
- John E. Lincoln
- Jan 20, 2021
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a ...
- Intermediate
- 60 Mins
- Roger Cowan
- Jan 20, 2021
EEO Compliance Update 2021: What Managers Need to Know About Protected Characteristics Now
If you are a supervisor, manager, HR professional or business owner, you – and the interests of your organization and its employees – will be well-served by developing a solid knowledge base with regards to key Equal Employment Opportunity (EEO) compliance con ...
- Basic & Intermediate
- 90 Mins
- Mary G White
- Jan 20, 2021
Sexual Harassment in the Workplace – Preventing Crossing that Line
Sexual Harassment in the Workforce training is designed for all employees, including the management team. Prevention can be accomplished by educating everyone on what sexual harassment is, how it is illegal in the workplace, what everyone’s responsibilities ar ...
- Basic & Intermediate
- 60 Mins
- Deborah Jenkins
- Jan 20, 2021