Search Trainings
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
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 ...
- Intermediate
- 90 Mins
- Loren Gelber
- Feb 26, 2019
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 ...
- Intermediate
- 60 Mins
- Roger Cowan
- Mar 05, 2019
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
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
- Mar 06, 2019
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 ...
- Intermediate
- 90 Mins
- Ginette Collazo
- Mar 06, 2019
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 ...
- Intermediate
- 60 Mins
- Denise Wrestler
- Mar 06, 2019
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 ...
- Intermediate
- 75 Mins
- Steven Wachs
- Mar 06, 2019
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 ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- Mar 06, 2019
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 ...
- Basic & Intermediate
- 90 Mins
- Erol Ali Cetino
- Mar 06, 2019