Drug Administration Web-based Seminars

GMP Compliance for Dietary Supplements - Webinar By GlobalCompliancePanel Overview: The U. S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. Wednesday, June 13, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Title 21 Code of Federal Regulations for Food and Drugs - Webinar By GlobalCompliancePanel Overview: United States Food and Drug Administration ("FDA") is the federal agency responsible for ensuring that foods are safe; drugs for human and animals, biologics and medical devices are safe and effective; electronic products that emit radiation as well as cosmetics are safe. Thursday, March 29, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Reusable Device Cleaning Disinfection and Sterilization Validations Overview and Key Design Considerations for Device Engineers Validation of reusable medical devices requires that the manufacturer develop methods for cleaning (after use) washing to remove all foreign matter possibly disinfecting and repackaging for the next use. The diversity of medical devices their intended use and classification in accordance with the food and drug administration requires that the manufacturer develop and validate the reprocessing  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...

What to Expect and How to Prepare for FDA Inspections - GlobalCompliancePanel ...cent headlines demonstrate, non-compliance with US Food & Drug Administration US FDA laws and regulations could cost your firm millions. In addition to significant revenue losses, violative US FDA inspections may also lead to injunctions, consent decrees, warning letters, FDA 483 's Notice of Inspectional Observations, product non-approvals, import detentions, recalls, criminal  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ... for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...ation * Current perspectives 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  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...g a drug or device for a use not approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote off-label may be  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...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.  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...