Search Trainings
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting regulatory compliance requi ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Mar 04, 2021
Controlling Human Error in the Manufacturing Floor
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
- Mar 09, 2021
Excel Spreadsheets: Ensuring Data Integrity and 21 CFR Part 11 Compliance
This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ...
- Basic & Intermediate
- 75 Mins
- David Nettleton
- Mar 18, 2021
Best Practices for Preparing for an FDA Computer System Validation Audit
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer syst ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Apr 06, 2021
The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate
- 120 Mins
- David Nettleton
- Apr 07, 2021
COVID-19 and Wage and Hour Issues under the FLSA
The COVID-19 pandemic has presented challenging wage and hour questions for employers. The federal Fair Labor Standards Act (FLSA)—and corresponding state wage and hour laws are not on hold during the pandemic. In addition to FLSA obligations, decisions regard ...
- Basic & Intermediate
- 90 Mins
- Janette Levey F
COVID-19 and Employment Law Issues
The Coronavirus may have brought much of the world as we know it to a temporary halt. Employment laws, and employers’ obligations, however, are not on hold. Employers still have an obligation to provide their employees a safe, workplace, free of harassment a ...
- Basic & Intermediate
- 90 Mins
- Janette Levey F
Proper CAPA Management
In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can a ...
- Intermediate
- 60 Mins
- Danielle Delucy
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
Establishing A Robust Supplier Management Program
Regulatory expectations are clear about manufactures’ responsibility regarding supplier quality oversight.All regulatory agencies agree that pharmaceutical and medical device manufactures are responsible for ensuring their suppliers adhere to quality standards ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas