Premarket Notification to Recalls - Comprehensive Medical Device Regulations Training Package

The following is a pack of 5 best-selling training CDs for regulatory professionals in the Medical Device industry. These courses provide information on how medical device companies can achieve compliance in the important stages of device development, marketing and maintenance.

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 elements of 510(k ) ; The 510(k) Process: Medical Devices classification - US and EU; Post Market Surveillance; Medical Device Complaints, MDR's and Recalls

Do not delay any more. Hurry ! Get the whole set at 55% flat discount.

All Modules:

Module 1: The 21 Elements of a 510(k)
Module 2: The 510(k) Process: Evaluating Substantial Equivalence in Premarket Notifications
Module 3: Classifying Medical Devices - US and EU
Module 4: Post Market Surveillance for Medical Devices
Module 5: Medical Device Complaints, MDR's and Recalls

Module 1 : The 21 Elements of a 510(k) - (Last Recorded Date: Dec-2016)

Areas Covered in the Webinar:

• Current Requirements of the FDA for a 510(k) submission
• Expected Sources of Information for Evaluation and Inclusion
• The 3 Types of 510(k) Submissions, and Their Uses
• Step-by-step analysis of the 21 Elements
• Changes to a Device after FDA Clearance
• Expected Submission Sequence of Events

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.

Module 2 : The 510(k) Process: Evaluating Substantial Equivalence in Premarket Notifications - (Last Recorded Date: Nov-2014)

Areas Covered in the Webinar:

• Device classification as it relates to 510(k)s
• Device classification
• Overview of 510(k) program
• Content of a 510(k)
• 510(k) submission process
• 510(k) decisions

Instructor Profile:

Ana Maria Saaibi has more than 6 years of medical device experience in both product development and quality and regulatory affairs. She has lead device work for both the U.S. domestic market and international markets. She has experience in medical device regulatory submissions to the FDA (US), INVIMA (Colombia) and Notified Bodies for the CE Mark as well as the development of quality management systems compliant with ISO 13485:2003, FDA QSR and MDD. Ms. Saaibi is an ASQ (American Society of Quality) certified biomedical auditor since 2012 and a RABQSA auditor in training.

Module 3 : Classifying Medical Devices - US and EU - (Last Recorded Date: Jan-2017)

Areas Covered in the Webinar:

• Medical device definitions
• US Medical device classifications
• EU Medical Device Classifications
• Key Terms and definitions
• Explain General and Special Controls and how they are applied
• Types of medical devices
• How US Medical devices are classified
• How EU Medical devices are classified
• List and describe the applicable US and EU regulations for medical device classification

Instructor Profile:

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – A regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.

Module 4 : Post Market Surveillance for Medical Devices - (Last Recorded Date: Jul-2017)

Areas Covered in the Webinar:

• The Structure of Post Market Surveillance
• US System
• Complaints (QSR)
• Medical Device Reports
• Corrections and Removals
• International Systems
• Complaints (ISO 13485)
• EU Vigilance
• EU FSCA and FSN
• Canada Adverse Event Reporting
• Post Production Information Collection
• Risk Management (ISO 14971)
• Clinical Evaluation (MDD Annex X)

Instructor Profile:

Daniel O'Leary, 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. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Module 5 : Medical Device Complaints, MDR's and Recalls - (Last Recorded Date: Jun-2016)

Areas Covered in the Webinar:

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

Instructor Profile:

John Chapman, BS, MBA, RAC has over 35 years’ medical device regulatory experience and over 15 years’ experience with the European Union’s medical device directive, 93/42/EEC. Mr. Chapman has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence for over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification.

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