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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
Understanding Human Error in Manufacturing: Methodology for Investigations
As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in manufacturing environments. Sadly, little is known about the nature of these events mainl ...
- Intermediate
- 90 Mins
- Ginette Collazo
- Jan 08, 2020
Corrective and Preventive Action - Your Most Important Process
While ISO 9001:2015 assigns corrective and preventive action to clauses 8.7 and 6.1 respectively, the same process can handle both activities and support other ISO requirements such as the organizational knowledge data base. It can also be extended to exploit ...
- Intermediate
- 75 Mins
- William A. Levi
- Jan 08, 2020
Non-conforming Material and Failure Investigations
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material.You’ll learn where non-conforming material can occur and ...
- Intermediate
- 90 Mins
- Susanne Manz
- Jan 09, 2020
Validation Master Plan - Written and Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Validation Master Plan, evaluating its elements ag ...
- Intermediate
- 90 Mins
- John E. Lincoln
- Jan 15, 2020
21 CFR Part 11 (Electronic Records and Signatures) Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jan 23, 2020
Acceptance Sampling for Process Validation and Production Lot Monitoring
Personnel involved in process validation and production control often rely on sampling methods to determine the suitability of a process before moving to production (process validation) or for checking production lots for acceptance. This webinar provides deta ...
- Intermediate
- 90 Mins
- Steven Wachs
- Jan 24, 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 ...
- Basic
- 60 Mins
- Danielle Delucy
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