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
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
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
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. Metrics for numerous departmental functional areas will be discussed; incl ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- Dec 19, 2019
FDA's Regulation of Over-the-Counter (OTC) Drugs Monographs and NDAs for Safety and Efficacy Goals
The three ways that the FDA regulates OTC (Over-the-Counter) drugs: Monographs, Rx to OTC switches and NDA/ANDA submissions, will be discussed in detail. Labeling and advertising of OTC drugs will be covered. Other requirements, including Registration, Drug Li ...
- Basic
- 75 Mins
- Loren Gelber
Reduce Compliance and Recordkeeping Burdens
This 90 minute webinar will cover strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies.An effective yet efficient quality system can be a competitive advantage for companies by leading to improved quality an ...
- Intermediate
- 90 Mins
- Susanne Manz
Proper Execution of Annual Product Reviews
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. Annual Product Quality Review ...
- Intermediate
- 60 Mins
- Danielle Delucy