WEBINARS

 

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

Post Market Surveillance for Medical Devices

webinar-speaker   Daniel O Leary

webinar-time   90 Min

Product Id: 702377

This 90-minute webinar covers all aspects of post market surveillance (PMS) for medical devices. It will direct you to the specific documents for the detailed information you need for an effective post-market surveillance system.

Recording Available

* Per Attendee $199

 

Medical Device vs. Consumer Device: Leveraging Technology to Help Patients and Caregivers

webinar-speaker   Tom Kramer

webinar-time   60 Min

Product Id: 705223

This training program will provide an understanding of key areas of design focus for medical wearables. Attendees will learn best practices to implement product development plan that apply to medical devices.

Recording Available

 

Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012

webinar-speaker   Daniel O Leary

webinar-time   90 Min

Product Id: 703752

Medical device manufacturers need systems to implement regulatory requirements (meeting customer requirements and handling regulatory complaints) as well as a business processes to determine customer satisfaction. While the three systems are related, each serves a different purpose. You will learn how to implement a customer satisfaction process to complete theses three important aspects.

Recording Available

 

What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

webinar-speaker   Rossano V Gerald

webinar-time   60 Min

Product Id: 705186

When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.

Recording Available

 

MDR Program conforming to New FDA Guidance

webinar-speaker   Edwin Waldbusser

webinar-time   60 Min

Product Id: 705149

FDA, in November 2016, issued a Guidance explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in nonconformances. This new Guidance attempts to eliminate confusion.

Recording Available

* Per Attendee $249

 

How to prepare a 510(k) FDA Submission

webinar-speaker   Edwin Waldbusser

webinar-time   60 Min

Product Id: 705024

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission.

Recording Available

 

Moving FDA Boundaries for Direct-to-Consumer Advertising

webinar-speaker   Casper Uldriks

webinar-time   90 Min

Product Id: 705033

FDA encourages companies that offer DTC advertising to include accurate information in their ads. Through a comprehensive surveillance and enforcement program, the agency ensures that consumers are not misled or deceived by advertisements that violate the law. This webinar will bring attendees up to speed so you are clearer about when DTC advertising makes you ripe for legal picking by the FDA.

Recording Available

* Per Attendee $179

 

Comparing the Pharmaceutical and Medical Device Product Lifecycles

webinar-speaker   Howard Cooper

webinar-time   120 Min

Product Id: 704853

This webinar will help you gain a greater understanding of regulatory and compliance requirements and how the early product lifecycle requirements establish the basic groundwork as a foundation from product development to commercialization continuing to out commercialization and product discontinuation.

Recording Available

* Per Attendee $249

 

Medical Device Complaints, MDR's and Recalls

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 700196

This training program on medical device complaint handling will discuss in detail the FDA regulations and the regulatory process with respect to medical device complaint handling, reporting and recalls.

Recording Available

* Per Attendee $179

 

Protecting Your Intellectual Property Abroad

webinar-speaker   Douglas Cohen

webinar-time   60 Min

Product Id: 702972

IP piracy costs more than a loss in sales. If your brand loses value because it is seen as less exclusive or is confused with poor imitations this poses a long term threat to profitability. Re-establishing brand identity and company reputation is expensive if not impossible. This webinar will provide specific, practical steps to take to lessen this risk of loss.

Recording Available

 

Standards and Their Role in Medical Device and Patient Safety

webinar-speaker   Lena Cordie Bancroft

webinar-time   90 Min

Product Id: 704654

This training program will explore the relationship of standards to medical device legal requirements. It will clarify the standards development process and discuss relationship of standards to patient safety.

Recording Available

 

Preparing for a UDI Implementation

webinar-speaker   Lena Cordie Bancroft

webinar-time   90 Min

Product Id: 704579

This training program will help attendees understand the requirements of the FDA UDI regulation and the labeling requirements of the UDI regulation. The program will also focus on data elements that make up a UDI compliant barcode and GUDID data attributes and submission process.

Recording Available

 

3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

webinar-speaker   Robert J Russell

webinar-time   3 hrs

Product Id: 704356

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

Recording Available

* Per Attendee $429

 

Preparing for FDA's Unique Device Identification Rule

webinar-speaker   Daniel O Leary

webinar-time   90 Min

Product Id: 702594

This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.

Recording Available

* Per Attendee $229

 

Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance

webinar-speaker   Cheryl Wagoner

webinar-time   60 Min

Product Id: 703223

This medical device webinar will discuss strategies for meeting the Post Market Surveillance requirements as described in Annex X of the MDD (MDD 93/42/EEC, updated per the 2007/47/EEC M5 amendment, Annex 1: Essential Requirements), MEDDEV 2.7.1, Dec 2009 and ISO 14155.

Recording Available

* Per Attendee $229

 

Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals

webinar-speaker   David Lim

webinar-time   120 Min

Product Id: 702318

This webinar will discuss requirements and compliance under the applicable FDA regulations for medical device reporting (MDR), recall and reports of corrections and removals in the US. It is designed to help the audience develop, maintain and implement adequate procedures.

Recording Available

* Per Attendee $249

 

Creating a Global Regulatory Plan

webinar-speaker   Cheryl Wagoner

webinar-time   60 Min

Product Id: 703283

This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Attendees will also gain exposure to the elements and a methodology for global regulatory plan development and maintenance.

Recording Available

* Per Attendee $229

 

Social Media for FDA Regulated Industry: Navigating the Web of Rules and Guidance

webinar-speaker   Michael Walsh

webinar-time   60 Min

Product Id: 703466

This webinar will provide an overview of regulations for the use of social media for promoting FDA regulated products. Attendees will learn how to comply with these regulations and avoid enforcement actions.

Recording Available

* Per Attendee $229

 

Health Canada’s Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Pharmaceuticals, Medical Devices and Natural Health Products

webinar-speaker   Sara Zborovski

webinar-time   60 Min

Product Id: 703830

The introduction of Vanessa’s Law in late 2014 has significantly changed the enforcement landscape, providing for the possibility of higher penalties than ever before in Canada. This training program will offer an overview of the new law and its potential impact on industry.

Recording Available

* Per Attendee $229

 

Canadian Advertising and Marketing of Pharmaceuticals, Medical Devices and Natural Health Products

webinar-speaker   Sara Zborovski

webinar-time   60 Min

Product Id: 703760

This webinar will provide attendees an overview of the relevant statutes, including the Competition Act, Food and Drugs Act and relevant regulations and information about the existence and operation of Canadian advertising pre-clearance agencies. The rules around advertising and marketing health products will be explained using examples, and hot topics in advertising and marketing will be covered, including the use of social media, testimonials and endorsements.

Recording Available

* Per Attendee $179

 

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