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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
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
Assessing Immunogenicity to Biologics
Immune responses in the patient population during clinical trials or during post-market pharmacovigilance are a serious issue facing biologic therapeutics. Similarity to critical proteins in human physiology or possible interference with endogenous pathways in ...
- Basic & Intermediate
- 90 Mins
- Gwen Wise-Black
- Mar 12, 2019
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
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, wh ...
- Basic
- 90 Mins
- Stefano Persian
- Mar 20, 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