Ghtf Web-based Seminars

Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences - Webinar By GlobalCompliancePanel This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements. The considerable use of graphical techniques will enhance this learning experience. Questions are strongly encouraged. Price  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ...gulations, and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements. The considerable use of graphical techniques will enhance this learning experience. Questions are strongly encouraged. Areas Covered in the Session: * Module 1 - Introduction to Quality and Compliance Concepts * Module 2 - Differences between  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why one should validate. Participants will learn how to comply with FDA and international  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...monization (ICH) and the Global Harmonization Task Force (GHTF) guidances. The attendees will quickly learn and understand the quality systems principles through the many graphical visual techniques used in the seminar. A quality systems approach will be shown that simplifies and reduces the burden of compliance. You might even want to revamp your quality system after participation in the  more...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the  more...

Medical Device Classification - Webinar by GlobalCompliancePanel In 1976, the FDA received authority to regulate medical devices. The plan, written into law, establishes three risk classes for devices (I, II, and III). The three risk levels require different types of control. The webinar explains the two dimensional sy The EUa ™s MDD classifies devices using a rule based system found in Annex IX of the MDD. Devices fall into four risk categories (I,  more...

Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel One of the most common reasons noted by the FDA for recalls of medical device is improper validation. It is also one of the most common reasons companies receive 483s and warning letters. Conversely, successful validations not only satisfy compliance and regulatory requirements, they also provide for robust manufacturing processes satisfying the needs of many individual functions within your  more...