Search Trainings
How to Properly Investigate OOS Results
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor, and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps an ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Nov 30, 2020
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
- Dec 01, 2020
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
- Dec 04, 2020
California Consumer Privacy Act
During this session we will discuss the California Consumer Privacy Act. Why it’s important and also, why are stricter rules and regulations being created. Is it with the public in mind?
- Basic & Intermediate
- 60 Mins
- Justin Muscolin
- Dec 08, 2020
Clinical Denials and Appeals
Aligning with the revenue cycle when there are clinical denials, is a challenging process for hospital case management department. The financial aspect of the revenue cycle receives denials for medical necessity, but payers may just be placing a particular den ...
- Basic & Intermediate
- 60 Mins
- Beverly Cunning
- Dec 10, 2020
Sample Size Determination for Design Validation Activities
Design Validation should ensure that product performance, quality, and reliability requirements are met. In order to have high confidence that products will perform as intended, enough data must be collected and analyzed using various statistical methods. Sel ...
- Basic & Intermediate
- 90 Mins
- Steven Wachs
- Dec 14, 2020
Clinical Trial Systems and Computer System Validation
This webinar will help you understand in detail the requirements for validating a computer system that is used in support of conducting clinical trials in compliance with FDA’s Good Clinical Practices (GCP). The approach is based on standard Computer System Va ...
- Basic & Intermediate
- 60 Mins
- Carolyn Troiano
- Dec 15, 2020
Implementation and Management of GMP Data Integrity
Data integrity is the assurance that data records are accurate, complete, intact, and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hy ...
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
- Dec 15, 2020
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