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114 results of "Life Sciences" and "Quality Mangement"
Live Webinar

The Identification and Quantitation of Low-Level Compounds for Impurity and Degradation Analyses

In the development and approval process for new medicines and pharmaceuticals, 2 important tests focus on compounds of low concentrations – impurity and degradation product analyses. Analytically this means identifying these compounds and assessing their amoun ...

  • Basic & Intermediate
  • 90 Mins
  • John Fetzer
  • Feb 26, 2019
Live Webinar

Equipment Qualification and Process Validation

FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated if changes are made o ...

Live Webinar

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 clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states:    “In aseptic processing, one of the most i ...

Live Webinar

USDA Final Genetically Modified Organism (GMO) Label Rule

The need for GMO labeling has been a hot topic for over 15 years. Scientific inquiry regarding the safety of GMO products has generated more questions that have been answered and has added fuel to the controversy. After extensive review and industry input, t ...

  • Basic & Intermediate
  • 60 Mins
  • John Ryan
  • Mar 06, 2019
Live Webinar

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 ...

Live Webinar

Human Error Reduction In GMP Manufacturing/Floor

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 ...

Live Webinar

CAPA Simplified – A One-form, Easy-to-Complete, Method for Simplifying your CAPA Process

This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), e ...

Live Webinar

Process Capability Assessment for Normal and Non-Normal Data

Companies must assure that their processes are capable of producing products and services that consistently meet customer specifications. This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for e ...

Live Webinar

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 ...

Live Webinar

Review of the Changes for ISO 13485:2016 Implementation and Comparison

The International Organization for Standardization (ISO) was established to share knowledge and develop voluntary, consensus-based, market-relevant standards that are designed to help support innovation and to provide solutions to tackle global issues. ISO is ...