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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
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
- Apr 15, 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
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
Useful Statistical Methods for Defining Product and Process Specifications
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time. If specifications are too wide, the risks of inadequa ...
- Basic & Intermediate
- 90 Mins
- Steven Wachs
- Apr 29, 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
- May 01, 2020
Modeling and Optimizing Process or Product Behavior Using Design of Experiments
Experimentation is frequently performed using trial and error approaches which are extremely inefficient and rarely lead to optimal solutions. Furthermore, when it’s desired to understand the effect of multiple variables on an outcome (response), “one-factor-a ...
- Basic & Intermediate
- 90 Mins
- Steven Wachs
- May 18, 2020
Remote Working – How to manage teams effectively when working from home
Our work the environment has changed significantly in the past week. Businesses must quickly adjust to having team members working from home. How do you effectively keep team members engaged and working together? This webinar will review important tips to m ...
- Basic & Intermediate
- 60 Mins
- Brian G. Rosenb
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a ...
- Intermediate
- 60 Mins
- Roger Cowan