European Web-based Seminars

ISO 13485 as a Quality Management System for Medical Devices - Webinar GlobalCompliancePanel This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. Thursday, February 16, 2012 10: 00 AM PST | 01: 00 PM EST  more...

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...

Working with the Pharmacopeias and Compendia - Webinar By GlobalCompliancePanel ...Every developed country has a pharmacopeia, including the European Union. This webinar will explore the function that the pharmacopeias play in the regulation and quality control of pharmaceutical products. The pharmacopeias play a key role in setting standards for individual pharmaceutical products. These standards are both for the physico-chemical properties of pharmaceuticals and for the  more...

ISO 13485 as a Quality Management System for Medical Devices by GlobalCompliancePanel This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ... will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its application to all medical products. They will better understand the importance of their role not only in maintaining the process but also in helping diagnosis and treatment of  more...

Recalls Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel ...ions. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firms' competitors. Areas Covered in the Session: * Complaint definitions - FDA, Canada & Europe * FDA's complaint handling requirements * Canada & European Union  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...ity management system, comparing it to ISO 9001 and FDA & European Union requirements. Why should you attend: International interest in certified quality systems is increasing. A Many foreign countries are now requesting medical device firm's supply them proof of certification to ISO 13485: 2003. To apply a CE mark under the Medical Device Directive, 93/ 42/ EEC, certification to ISO 13485  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ... 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 Medical Devices and Pharmaceuticals * Module  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...ctives from the U. S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Australian Therapeutic Gods Administration (TGA) and the Japanese Pharmaceutical and Medical Devices Agency (PMDA) * Use of comparability protocols * Submission strategies * Concept of research exemptions Who Will Benefit: * Microbiology * Quality Control * Quality  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...on up to par with the advanced and modern expectations of European authorities and CDER's sister medical device division. The new requirements expand validation from a one-time activity into a full lifecycle philosophy, encompassing statistics, risk management, project management, and new technologies. No one involved in process development and validation in the drug, API, or biologics  more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel ...macopoeia testing requirements from the United States and European Pharmacopeias (USP and Ph. Eur.) * Acceptance criteria Who Will Benefit: Senior management and laboratory personnel responsible for the conduct of microbiological testing and microbial control strategies in manufacturing and product/ process development: * Microbiology * Quality Control * Quality  more...

ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device  more...

European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel This webinar will describe European PV requirements, including compliance with applicable laws, regulations and guidance. In addition, attendees will learn how to compare the company's PV operations to applicable best practices in Europe.  more...