WEBINARS

 

Medical Device Marketing and Promotion Regulatory Compliance Training - Live Webinars, Recordings & CDs

FDA's Ambitious Regulation of Social Media

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

Recording Available

* Per Attendee $279

 

Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 700986

This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.

Recording Available

* Per Attendee $299

 

ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

webinar-speaker   Betty Lane

webinar-time   60 Min

Product Id: 702871

This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2019 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.

Recording Available

* Per Attendee $299

 

Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 701369

This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.

Recording Available

* Per Attendee $299

 

Veterinary Medical Devices and FDA’s Regulatory Oversight

webinar-speaker   Karl M. Nobert

webinar-time   60 Min

Product Id: 703769

This webinar will make your understand regulatory requirements of veterinary medical device. How to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements, how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.

Recording Available

* Per Attendee $399

 

Successful 510(k) Submissions

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 700815

In this 510(k) submission process webinar attendees will learn the different types of 510(k)s, 21 required elements in the traditional 510(k) and how are they addressed and documented. Also attendees will learn software / firmware requirements, De Novo submission for obtaining marketing clearance for medical devices in the U.S.

Recording Available

* Per Attendee $399

 

Japan: Regulatory Compliance Requirements for Life Science Products

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702979

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.

Recording Available

* Per Attendee $299

 

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

webinar-speaker   Vanessa Lopez

webinar-time   90 Min

Product Id: 704758

This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.

Recording Available

* Per Attendee $299

 

Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702038

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Recording Available

* Per Attendee $299

 

The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 705111

This webinar will focus on the IEC standard and its key requirements: “IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices”. It will touch on “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Another webinar will focus on Part 2, and re-evaluate key portions of Part-1.

Recording Available

* Per Attendee $299

 

Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 700831

This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

Recording Available

* Per Attendee $299

 

Complaint Handling, MDR's & Recalls

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 700830

This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

Recording Available

* Per Attendee $299

 

Human Factors Engineering in New Product Development

webinar-speaker   Tom Kramer

webinar-time   120 Min

Product Id: 705153

This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant.

Recording Available

* Per Attendee $249

 

Medical Device Tracking Requirements

webinar-speaker   Vanessa Lopez

webinar-time   60 Min

Product Id: 705192

Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately.

Recording Available

* Per Attendee $249

 

Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 701788

This Medical device complaints handling webinar will discuss the best practices of complaint handling and how to include it in your CAPA program and how to apply risk management to the complaint handling system.

Recording Available

* Per Attendee $249

 

Classifying Medical Devices - US and EU

webinar-speaker   Charles H Paul

webinar-time   60 Min

Product Id: 705045

The Medical Device Classification webinar explains the classification system in US and the EU.

Recording Available

* Per Attendee $229

 

Stability and Shelf Life of Medical Devices

webinar-speaker   Stephanie Cooke

webinar-time   90 Min

Product Id: 705485

This webinar will cover all relevant regulatory requirements (CFR, FDA, ISO, ASTM and European) for establishing the stability and determining the shelf-life of medical devices. Attendees will gain a better understanding of the design control process for designing medical devices.

Recording Available

 

Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 700184

This webinar on selling medical devices in the European Union (EU) will immensely benefit companies wishing to penetrate the EU market for medical devices or sharpen their skills. It will provide practical guidance on achieving the CE mark. Medical devices sold into the European Union (EU) must comply with the applicable medical device directives and EU laws similar to FDA’s regulations.

Recording Available

* Per Attendee $249

 

ISO 9001 and ISO 13485 Upgrades and Impact on the Industry

webinar-speaker   Carmine Jabri

webinar-time   60 Min

Product Id: 705449

This webinar will focus on the recent changes to the ISO 9001 and ISO 13485 quality management system (QMS) standards. Participants will be provided with the tools necessary to help their company plan for the transition to the new editions.

Recording Available

 

How to Establish and Maintain a Design History File for a Medical Device

webinar-speaker   Mary Nunnally

webinar-time   60 Min

Product Id: 705287

This device compliance training will offer a basic understanding of the records required to fulfill requirements of both US FDA 21 CFR 820 and ISO 13485:2016 for establishment and maintenance of a Design History File (DHF). It will also help attendees understand what document control means for DHF records.

Recording Available

* Per Attendee $229

 

 

 

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