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
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
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
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
- Dec 15, 2020
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
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
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
- Intermediate
- 90 Mins
- Ginette Collazo