Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? Areas Covered in the Session: Why water myths develop Impact of c-GMPs Well-meaning but misguided precedents Scientifically unch...

Overview: The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue an order. Specifically, section 519(e), as added...

Overview: Companies must provide effective Food Safety training for all employees including managers, supervisors, sanitation employees and production employees in order to produce a safe quality food product. The objective of this presentation is to equip the participants with the basic skills and knowledge to properly perform a titration drop count test on food plant chemical cleaners and sanitizers. The participants will also be presented w...

Overview: Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success. The following subjects will be covered in detail: Material...

Overview: The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making. Areas Covered in the Session: Population and Samples Basic Statistics Common Applications requiring s...

Overview: Outsourcing and contracting is continuing to increase in the pharmaceutical industry. Regulations have been in place for some time specifying requirements that ensure that appropriate controls are in place. This webinar will discuss the history of the regulations with emphasis on changes particularly specific to the Good Manufacturing Practices A short overview of the GMP’s quality systems will provide an overall picture of how...

Overview: Companies must provide effective chemical safety training for all employees including managers, supervisors, operators and temporary workers. The objective of this presentation is to equip the participants with the basic skills and knowledge to assess chemical hazards in their workplace. The participants will also be presented with basic controls for working safely with chemical detergents and sanitizers used in food processing plant...

Overview: This training will address the export audit compliance procedures that will emphasize what appropriate documentation that are often used in the country market system and its product competitiveness research methods for conducting trade transactions. It focuses on identifying the customers, such as the end users, distributors, and sales agents and examine the compliance procedures within foreign law justification. Lastly, we address t...

Overview: Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions.Why should you attend: Understand how the use of a unique device identification (UDI) system may improve patient safety, e.g., by reducing medical errors, facilitating device recalls, and im...

Overview: Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is be...