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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
Risk Based Approach to Auditing Quality Suppliers and Vendors
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implem ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- Mar 19, 2019
PK/PD Studies in Drug Discovery and Development
Pharmacokinetics (PK) describes the time course of drugs in the organism i.e. the processes that a drug undergoes after administration. PK, therefore, assesses the absorption, distribution, metabolism, and excretion of new chemical entities. In other words, ...
- Basic
- 60 Mins
- Stefano Persian
- Mar 20, 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
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
Validation of Complex Cell-Based Potency Methods
This webinar will address development and validation of complex cell-based methods some cell-based methods are multifaceted Will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, Will also discu ...
- Basic & Intermediate
- 60 Mins
- Gwen Wise-Black
- Apr 04, 2019
Understanding and Implementing a Technology Transfer Process
The purpose of this training is to provide you with an overview of the Technology Transfer Define technology transfer Identify New Product transfer process Identify elements of the business process framework for managing technology transfers Explain bene ...
- Basic & Advanced
- 60 Mins
- Steven Laurenz
- Apr 09, 2019
Human Factors/ Usability Studies following ISO62366 and the New FDA Guidance
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the ef ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
- Apr 17, 2019
The Human Error Tool Box: A Practical Approach to 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. From p ...
- Intermediate
- 90 Mins
- Ginette Collazo
- Apr 17, 2019