From Premarket Notification to Recalls - Comprehensive Medical Device Regulations Training Package

In today's complex regulatory environment, medical device manufacturers often find that the road to compliance can be filled with unseen perils that can lead to warning letters or worse. Every step in the development process is regulated and non-compliance can be a huge liability for companies.

To help medical device companies achieve compliance in the important stages of device development, marketing and maintenance, we have created a comprehensive training webinar recording CD package covering areas such as the FDA's 2011 revised 510(k) premarket notification process; the Investigational Device Exemption; Document approval, control and distribution; Premarket Approval (PMA) agreement; medical device classification; post market surveillance; device establishment and registration; and medical device recalls.

How It Works:

Each webinar CD has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don't have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

Webinar Topics:

• FDA's 2011 Revised 510(k) Premarket Notification Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions & Regulatory Compliance
• The IDE (Investigational Device Exemption) - It's Purpose and Preparation
• Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements
• FDA's Proposed Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List
• Medical Device Classification - US and the EU as per MDD, CMDR and GHTF
• Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements
• Post Market Surveillance in Today's Regulatory Environment
• Medical Device Complaints, MDR's and Recalls

Who will benefit?

These webinar recording CDs will be beneficial to the following:

Management and personnel from all departments who wish to remain abreast of key changes in FDA CDRH policies; QA/QC/Compliance/Regulatory Affairs; Engineering/R&D/Technical Services; Marketing; Consultants; Operations/Manufacturing/Validation; Clinical trial administrators / monitors; Documentation Control personnel; Venture Capitalist; Design Engineers; Quality System Auditors

Webinars included in the Package:

FDA's 2011 Revised 510(k) Premarket Notification Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions & Regulatory Compliance (Duration: 80 minutes)

This 510(K) training webinar helps you understand and be prepared for substantial changes to the Premarket Notification 510(k) process for Class II medical devices.

Areas Covered in the Webinar:

• An intensive, brief but in-depth review of FDA's current policy relating to the 25 recommendations the Agency has states it intends to implement in 2011;
• Discussion of the FDA projected timeline for completing milestones for revamping the 510(k) review process;
• Specific discussion of the essential tactical activities and procedures that should be adopted by manufacturers this year to streamline compliance with the new regulatory requirements and FDA policy changes;
• Review and discuss three free template documents prepared by the presenter, an FDA Regulatory Attorney
• Discussion of the most common flaws and pitfall in product development programs that increase the regulatory burden on a manufacturer under the new FDA 510(k) process.
• Practical and immediate steps to take to dramatically reduce the cost of regulatory compliance for Class II/III devices.
• Long-term strategies to ensure an efficient product development program.

About the Instructor:

Robert J Michalik , Esq, RAC, has over 20 years' experience and is a regulatory attorney in Massachusetts and founder of RegulatoryPro.com, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries.

The IDE (Investigational Device Exemption) - It's Purpose and Preparation (60 minutes)

This IDE (Investigational Device Exemption) webinar covers its purpose and preparation, recommended subject headings, content submission and follow-up usage in clinical trial(s).

Areas Covered in the Webinar:

• The purpose of the IDE (Investigational Device Exemption).
• Expectations of the FDA.
• Its preparation -- recommended subject headings and content Submission and follow up Usage in the clinical trial(s) -- The IRB and "Informed Consent".
• What you can and can't do with product prototypes and their labeling Use in a follow-on 510(k).

About the Instructor:

John E. Lincoln , consultant, has successfully designed, written and run all types of qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops worldwide.

Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements (60 minutes)

This webinar reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.

Areas Covered in the Webinar:

• Why a modular PMA.
• Modular PMA agreement with the FDA.
• Organizing each Module.
• Review time for each module.
• Manufacturing Module.
• Clinical Module.
• Class Audit of Manufacturing Facility up to 17 days.

About the Instructor:

E.J. Smith is a co-founder of Smith Associates, a FDA regulatory consulting firm that specializes in the preparation of 510(k), PMA and IDE submissions, device and cosmetic labeling, quality system audits and clinical trials.

FDA's Proposed Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List (76 minutes)

This webinar discusses the proposed Device Establishment Registration and Listing rule and how to meet the FDA requirements and expectations.

Areas Covered in the Webinar:

• When and how to register and list.
• Review the four proposed changes to FDA's device establishment registration and device listing regulations.
• Proposed changes to Implement the provision of Bioterrorism Act applicable to imported devices.
• Other proposed Amendments that would change current device establishment registration and listing requirements.
• Replacement of the current regulations regarding updating device listing information outside the required update periods.
• Clarification of who must provide establishments' registration numbers.

About the Instructor:

David R. Dills , an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the life sciences and FDA regulated industry, has an extensive regulatory background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory landscape.

Medical Device Classification - US and the EU as per MDD, CMDR and GHTF (75 minutes)

This webinar explains the classification system in the US , the EU, following the Medial Device Directive (MDD), and the Canadian Medical Device Regulations (CMDR), and the guidance from the Global Harmonization Task Force (GHTF).

Areas Covered in the Webinar:

• The Concepts Of Medical Device Risk.
• Classification in the US.
• Classification in the EU (MDD).
• Classification in Canada.
• GHTF Guidance.

About the Instructor:

Daniel O'Leary has more than 30 years of experience in regulated industries and is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management.

Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements (75 minutes)

This webinar explains how to use electronic systems for document control, without 21 CFR part 11 implications.

Areas Covered in the Webinar:

• History of document control.
• FDA requirements for document control.
• ISO 13485 requirements for document control.
• Elements/practices of a typical document control system.
• Elements/practices of a streamlined document control system.
• How to use electronic systems for document control, WITHOUT 21 CFR part 11 implications.

About the Instructor:

Jeff Kasoff , RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields.

Post Market Surveillance in Today's Regulatory Environment (60 minutes)

This webinar will discuss how the Postmarket initiative of FDA affects your company and how to keep ahead of potential problems by knowing common, but avoidable, mistakes. Recent warning letters will also be examined to learn how the FDA views complaint handling, reporting and recalls.

Areas Covered in the Webinar:

• What is the FDA doing in postmarket serviellance.
• Top 5 mistakes in postmarket surveillance.
• How might my company be affected and what can we do.
• How will the FDA Postmarket Transition Initiative affect how you receive and analyze complaints.
• MDRs and Adverse Events - to report or not to report.
• Four steps to better complaint follow-up.
• Three sources new and emerging sources of customer feedback.
• How to assess your recall risks.

About the Instructor:

Judy M Andrews , Ph.D is Director of Quality and Compliance Services at Medical Device Consultants in North Attleboro Massachusetts . She has over twenty years of hands-on experience in the FDA regulation of medical devices.

Medical Device Complaints, MDR's and Recalls (60 minutes)

This webinar discusses in detail the FDA regulations and the regulatory process with respect to medical device complaint handling and reporting.

Areas Covered in the Webinar:

• FDA's Complaint Definition 820.3 (b).
• Complaint Documentation.
• Part 803 - Medical Device Reporting.
• Part 806 - Reports of Corrections & Removals.
• Warning letters and other FDA Remedies.
• Complaint Handling Pitfalls.

About the Instructor:

John Chapman , BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC.

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