Overview: This webinar will cover fundamental extrusion processing hardware as well as how that hardware is operated in order to produce the desired product. Both single and twin screw extruders and their differences in operating characteristics will be covered. Why should you Attend: Extrusion processing is a complex process and is regarded as a science with a healthy dose of art, typically requiring many years of practice to master. Areas Co...

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Why should you Attend: FDA expects that as part of a product development program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is the most powerful of...

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection. Why should you Attend: FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lesse...

Cyber-attacks and breaches dominate the media and are a significant focus of the government. Businesses and financial institutions are faced with the grim reality that a cyber-attack is inevitable. It's not a matter of if an attack will occur, only when. Why should you Attend: A poor response is often more damaging that the cyber-attack itself. According to recent reports, cyber-attacks cost the average American business $15.4 million per year...

To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and establishment of a training program, including new employe...

During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities. Regulatory Requirements EU/US The webinar will clarify the regulatory requirements of combination products and address life-cycle management Examining the regulatory requi...

With $49 billion worth of imported foods, the FDA and its regulatory allies oversee more than 420,000 domestic and foreign facilities. Importers of food products intended for introduction and consumption in the United States through international commerce are responsible for ensuring that the products are safe, sanitary, wholesome, and labeled according to U.S. requirements. Over 70% of all seafood and 35% of all produce consumed in the U.S. a...

Learn from Excel expert David H. Ringstrom, CPA, how to create resilient and practical budget spreadsheets in this informative webcast. David shares a wide range of helpful techniques, including how to separate inputs from calculations, streamline formula writing, preserve key formulas, and create both operating and cash flow budgets. In addition, he explains the uses and benefits of a variety of Excel functions, including CHOOSE IFNA, IFERROR...

This webinar can help you be more professional and polished during an inspection. You will learn how to present information about your quality system in the most competent and professional manner. Why should you Attend: This webinar can help you prepare a strategy and detailed plan to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection. If you've had a recall, an increase in MDRs, or it's been more than 2 y...

If you're like millions of other business professionals, you probably use Microsoft Outlook every day to manage your email, calendar and to do's. It's available for Windows, Mac, mobile and there's even a web version. In this session you will learn how to control Outlook, rather than letting it control you. Why should you Attend: In this session you'll learn how, used in the right way, Outlook can save you time, help you to gain more control,...