FDA Issues Final Rule on Symbols in Labeling
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.
Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
FDA Issues Final Rule on Symbols in Labeling
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.
Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Complaint Handling and Management: From Receipt to Trending
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
FDA Issues Final Rule on Symbols in Labeling
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Complaint Handling and Management: From Receipt to Trending
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Complaint Handling and Management: From Receipt to Trending
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
FDA Issues Final Rule on Symbols in Labeling
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met. FDA back in June 2016 issued a final rule to allow for the use of standalone symbols on medical device and in vitro diagnostic (IVD) labels in an effort to align with international standards. In addition to allowing the use of standalone symbols, the final rule also permits the use of the symbol statements "Rx only" and "Rx only" for prescription devices. FDA says the finale rule is optional, though the agency thinks that it will be a boon to industry and estimates the reduced workload will result in annual savings of up to $25.5 million.
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Complaint Handling and Management: From Receipt to Trending
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Bullet Proof 510(k) - Latest FDA Changes to the Process
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends
CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Postmarketing Vigilance Reporting For Medical Device Manufacturers
Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 6) came into force on January 1, 2008.
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Managing Your Medical Device Reporting (MDR) Program for Compliance Success
Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly.
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Update on Unique Device Identifier for Device Manufacturers
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.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Combination Products: FDA's Final Rule for GMP Requirements
What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Construct and Manage the Technical File and Design Dossier
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape.
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Complaint Handling and Management: From Receipt to Trending
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Conducting Successful Product Complaint Investigations
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Conducting Successful Product Complaint Investigations
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Postmarketing Vigilance Reporting For Medical Device Manufacturers
Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 6) came into force on January 1, 2008.
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products
What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?
Speaker: David R Dills | View Anytime | Price: ¤190.00 | View Details
Draft Guidance for Device Industry and FDA - Postmarket Surveillance
This webinar will provide an overview and guidance to firms that are either going through or preparing to go postmarket surveillance activities.
Speaker: David R Dills | View Anytime | Price: ¤154.00 | View Details
Bullet Proof 510(k) – Latest FDA Changes to the Process
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.
Speaker: David R Dills | View Anytime | Price: ¤158.00 | View Details
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.
Speaker: David R Dills | View Anytime | Price: ¤148.00 | View Details
Complaint Handling and Management: From Receipt to Trending
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Price: ¤155.00 | View Details
Establish and Maintain an Effective Supplier Qualification Program
FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: ¤139.00 | View Details
Conducting Successful Product Complaint Investigations
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View Details
Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products
What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View Details
Bullet Proof 510(k) – Latest FDA Changes to the Process
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.
Speaker: David R Dills | View Anytime | Duration: 3 Hours | Price: ¤189.00 | View Details
Complaint Handling and Management: From Receipt to Trending
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View Details
Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends
CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.
Speaker: David R Dills | View Anytime | Price: ¤189.00 | View Details
How to Manage a Medical Device Recall Efficiently and Effectively
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
Speaker: David R Dills | View Anytime | Price: ¤189.00 | View Details
FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators
This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and working with clinical investigators.
Speaker: David R Dills | View Anytime | Price: ¤189.00 | View Details
FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List
Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.
Speaker: David R Dills | View Anytime | Price: ¤189.00 | View Details