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Standadardizing Operations to Eliminate Human Error Potential in Life Sciences Operations
Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients. Human is a frequent occurrence in pharmaceutical manufacturing. It occurs even ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- Mar 19, 2019
FDA – Is your cGMP Water System READY for their VISIT
Pharma cGMP Water Systems are very critical to the safe production of patients modifications. Several Departments are required for continued High-Quality operations. These include Quality, Manufacturing, Maintainence and Validation on a daily basis. This prese ...
- Intermediate
- 90 Mins
- Peter T. Vishto
- Mar 19, 2019
FDA Regulations for Pharmaceutical Current Good Manufacturing Practice (cGMP)
This webinar will review all the sections of FDA cGMP regulations. Regulation text and examples from the instructor’s experience will be presented. Warning Letters and Inspectional Observations will be used as examples of what not to do.
- Basic
- 90 Mins
- Loren Gelber
- Mar 26, 2019
Technical Writing: Best Practices
Technical Writing generally conforms to Good Documentation Practices (GDocP). This term describes standards to create and maintain documents. The term is primarily associated with the pharmaceutical and medical devices industries but applies to documents creat ...
- Basic
- 60 Mins
- Robert Peoples
- Mar 27, 2019
Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design ...
- Intermediate
- 60 Mins
- José Mora
- Mar 28, 2019
Environmental Monitoring for Pharmaceutical Clean Rooms
This webinar will discuss various broad and critical aspects of an effective EM program such as the Phases of a cleanroom EM Program, Pre-Monitoring of a Cleanroom prior to Facility Validation, Facility Validation, Implementation of Routine EM using Facility V ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- Mar 28, 2019
Best Practice for Complaint Handling in Compliance with FDA and ISO Regulations
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may dete ...
- Intermediate
- 60 Mins
- Jeff Kasoff
- Mar 29, 2019
Knock, Knock, Who’s There? Preparing for an FDA Inspection
Are you ready for that knock on your door? Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage i ...
- Intermediate
- 90 Mins
- Susanne Manz
- Apr 02, 2019
Steam Sterilization Microbiology and Autoclave Performance Qualification
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization proc ...
- Basic & Advanced
- 60 Mins
- Danielle Delucy
- Apr 02, 2019
New GCP Compliance Requirements for Clinical QMS
Currently pharmaceutical and medical device industry guidance for quality in clinical development is fractured across multiple documents from multiple sources. Also, with the implementation of ICH GCP R2, it is expected that the CQMS should be risk-based. Reg ...
- Basic & Intermediate
- 60 Mins
- Laura Brown
- Apr 02, 2019