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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Part of any comprehensive HR audit is auditing your organization's Family and Medical Leave Act (FMLA) practices. While auditing FMLA is time-consuming, it is worth the investment of time. Because of the Department of Labor (DOL) investigates your FMLA practic ...
The MOR verity’s that property owners and management agents are in compliance with HUD and other federal regulations and their Housing Assistance Payments (HAP) contract. We will walk you through all of the steps of the MOR review. With good preparation, you w ...