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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
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most im ...
- Intermediate
- 60 Mins
- Roger Cowan
- Feb 23, 2021
Time Extension Requests – What Does A Contractor Have to Prove?
Be exposed to two recent cases concerning time extension requests Learn the rules concerning time extension requests Understand the arguments about waiver and apportionment of liquidated damages Become knowledgeable about concurrent delay issues and who m ...
- Intermediate
- 90 Mins
- James G. Zack
- Feb 23, 2021
Mediating Construction Disputes – How to Stay Out of Arbitration & Litigation
Mediation is not new. Mediation was employed in ancient India as well as in the Islamic world.In more recent times mediation has been widely adopted in the U.S. construction industry as a form of Alternative Dispute Resolution (ADR). Mediation is often employe ...
- Advanced
- 90 Mins
- James G. Zack
Form 1099 Compliance Changes for 2020
This course will explain the changes relating to Form 1099-MISC for 2020, in particular the changes to how contract labor pay is reported. The IRS has created a new form, called Form 1099-NEC, where contract labor pay will be reported. We will cover these chan ...
- Intermediate
- 60 Mins
- Jason Dinesen
Contract Killer Clauses Under COVID-19 and How to Neutralize Them
Now that cornavirus is foreseeable and not necessarily a force majeure event, you need to update your risk allocation strategies for COVID-19 risks. Learn what to look for with real world examples of COVID-19 killer clause at the prime and subcontract level. L ...
- Basic & Intermediate
- 60 Mins
- Brian Perlberg
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
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
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