Search Trainings
FDA’s Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes development of a company philosophy and approach, and incorporating it into an overall computer system v ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Nov 20, 2019
Risk-based Design Control - The New Paradigm for Medical Device Design
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. Design control is not only a requirement of th ...
- Basic & Intermediate
- 60 Mins
- José Mora
- Nov 20, 2019
Backup Communications for Medical Facilities – New Federal Regulations Affect Healthcare Providers and Amateur Radio
Amateur Radio’s primary purpose for existing is to provide backup communications in times of disaster. The webinar presents methods used to provide communications when Internet and Phone Systems are not accessible due to human-made or natural disasters.
- Basic
- 60 Mins
- Michael Abitz
- Nov 21, 2019
FDA Best Audit Behavior Practices – Do’s and Don’ts
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, a ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- Nov 22, 2019
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.Fro ...
- Basic & Advanced
- 90 Mins
- Ginette Collazo
- Nov 26, 2019
Understanding Initial IND Submission- The first 30 days
This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider placing a clinical ...
- Basic & Intermediate
- 60 Mins
- Gowri Sukumar
- Nov 26, 2019
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 ...
- Basic
- 60 Mins
- Danielle Delucy
- Dec 04, 2019
Avoiding Death by CAPA – What you need to know
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. ...
- Basic & Advanced
- 90 Mins
- Susanne Manz
- Dec 10, 2019
Manufacturing Quality Agreements- Qualifying Suppliers & Managing Quality in FDA-Regulated Industries
Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. In 2016, ...
- Intermediate
- 75 Mins
- Joy L. McElroy
- Dec 10, 2019
How to Write Sop'S that Avoid Human Error
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Proced ...
- Advanced
- 90 Mins
- Ginette Collazo
- Dec 11, 2019