Search Trainings
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. ...
- Intermediate
- 90 Mins
- Susanne Manz
- Apr 09, 2020
Medical Device Trends for Computer Systems Regulated by FDA
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information: You will learn about the Cen ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Apr 14, 2020
Master Verification and Validation Planning per US FDA and EU MDR / ISO
Review a company's Verification and Validation System for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evalu ...
- Intermediate
- 60 Mins
- John E. Lincoln
- Apr 14, 2020
Predicting Product Life with Reliability Analysis Methods
Participants will gain awareness of the overall methodology for setting reliability targets, estimating product reliability from test data and/or field data, and determining whether or not reliability targets are achieved. Participants will also learn how to ...
- Basic & Intermediate
- 90 Mins
- Steven Wachs
- Apr 15, 2020
Qualification of Contract Software Developers based on Practical Experience
This webinar will explain the regulatory requirements and a risk based procedure to qualify and manage suppliers that develop software for your company. The phases of the selection process, from compiling a list of candidate developers through the qualificatio ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Apr 16, 2020
Developing an Effective CAPA Management and Root Cause Analysis System
In many companies, deviation/non-conformance investigations are often criticized for the lack of a robust root cause analysis. Proper root cause can help a company in many ways. Root cause analysis helps identify what, how and why something happened, thus prev ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Apr 16, 2020
How To Manage Your Emotions During a Crisis
Our brains are programmed to react to crisis and perceived threats in a very specific way. You’re probably experiencing that right now, but it doesn’t have to be that way – we can reprogram our brains, our thoughts and emotions. With so much that’s happening o ...
- Basic & Intermediate
- 60 Mins
- Michael Healey
- Apr 16, 2020
How to Reduce Human Error Once and for All ?
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. From p ...
- Intermediate
- 90 Mins
- Ginette Collazo
- Apr 21, 2020
Another Outbreak, Another Recall
After more spending than 48 years as an environmental microbiologist and food safety advocate, I have come to the sad realization that many practitioners associated with the food industry have not adopted the basic tenets of a food safety strategy: Prevention ...
- Basic & Intermediate
- 60 Mins
- Michael Brodsky
- Apr 23, 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
- Apr 23, 2020