Course Description

Understanding, implementing and ensuring compliance with quality system regulations is key to creating quality devices that are safe to use. Adhering to QSR and regulations such as the European Medical Device Directive (EU MDD) and the ISO 13485 Quality Management System help a manufacturer make reliable products. To help medical device companies and their employees understand the multiple requirements of quality system regulations better, ComplianceOnline is conducting a seminar series over three days focusing on the following regulatory areas:  
Course "Medical Device Seminar Series: QSR, Design Control and Pre-Market Submissions" has been pre-approved by RAPS as eligible for up to 18 credits towards a participant's RAC recertification upon full completion.
Attend one or more courses. Mix & Match courses. Select most suitable course(s) for you, your colleagues or team.

Date & Time
By - Dan O' Leary (Track 1)		  
By - David Lim (Track 2)
Day 1
Wednesday, October 31, 2012
Time: 9 AM to 4 PM PDT 		FDA's Quality System Regulation OR An Interactive Workshop on Design Control for Medical Devices Including In Vitro Diagnostic Devices
Day 2
Thursday, November 1, 2012
Time: 9 AM to 4 PM PDT 		The ISO 13485 Quality Management System OR An Interactive Workshop on Premarket [510(k)] Notification Submissions
Day 3
Friday, November 2, 2012
Time: 9 AM to 4 PM PDT 		The Medical Device Directive OR An Interactive Workshop on Auditing and FDA Quality Management System (QMS) For Medical Devices Including In Vitro Diagnostic Medical Devices

Note: Each day’s courses will run simultaneously. So you can attend any one course in a day. However you can purchase both the courses of a day for your colleagues or team.
Attend different courses of same day with colleagues and team to share the learning.
Also you can buy any 1, 2 or all 3 courses of a track or mix and match courses of 2 tracks to make it any 3 courses. Group discounts are available.


Track 1 Seminars


Day 1 - FDA's Quality System Regulation:

The FDA’s Quality System Regulation (QSR) is the required Quality Management System (QMS) for device manufacturers who market their products in the US, regardless of the manufacturing location in the world.

Understanding the QSR is important for device manufacturers to build an effective and compliant system. The workshop takes you through the regulatory requirements and explains how to implement them. The workshop provides guidance on the regulatory requirements and explains how they support the safe and effective manufacture of medical devices.

Day 2 - The ISO 13485 Quality Management System:

This workshop explains the history of ISO 13485 and its relationship to ISO 9001. We look at specific regional differences, such as the European Union’s EN ISO 13485:2012. ISO 13485 has a guidance document, ISO/TR 14969, which provides valuable information on applying ISO 13485.

Day 3 - The Medical Device Directive:

The seminar covers the organization of the medical device directive and shows how it controls the product life cycle. We start from determining the device class to allowable conformity assessment paths. The seminar includes the Essential Requirements and their relation to harmonized standards and clinical evaluation. We examine the purpose of the technical file (or design dossier). In addition, the seminar covers clinical evaluation and clinical follow-up.

Who will Benefit:

This seminar is valuable to anybody involved in medical device design and manufacturing for the European Union. The employees who will benefit include:

  • Research and development
  • Production
  • Regulatory affairs
  • Quality assurance
  • Quality control
  • Senior and executive management

Track 2 Seminars


Day 1 - Design Control for Medical Devices:

At this workshop, Dr. David Lim will walk you through to get familiar with the "Establishing Design Control for Medical Devices Including In Vitro Diagnostic Medical Devices (IVDs)". This workshop is intended to provide guidance on interpreting, understanding, establishing and maintaining design control for all classes of medical devices including IVDs.
During this workshop (October 31), defining, documenting and implementing design control procedures for medical devices including in vitro diagnostic devices will be discussed.

Day 2 - Premarket [510(k)] Notification Submissions:

At this workshop, Dr. David Lim will walk you through to get familiar with the "510(k) Format and Contents".
This workshop is intended to provide guidance on how to format 510(k) submissions including necessary contents to proactively facilitate the FDA review process for medical devices including in vitro diagnostic devices.

Day 3 - Auditing and FDA QMS For Medical Devices:

At this workshop, Dr. David Lim will walk you through to get familiar with the "Auditing and FDA Quality Management System for Medical Devices Including In Vitro Diagnostic Medical Devices". This workshop is intended to provide guidance on establishing and following auditing and quality management system for medical devices including in vitro diagnostic devices.

Who will Benefit:

The following employees who will benefit include:

  • Regulatory affairs (associates, specialists, managers, and directors)
  • Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
  • Research and development (associates, scientists, managers, directors and VPs)
  • Product and development (associates, scientists, managers, directors and VPs)
  • Contract research organization (associates, scientists, managers, directors and VPs)
  • Site managers, and consultants
  • Senior and executive management (VPs, SVPs, Presidents and CEOs)
  • Contractors and subcontractors
  • Anyone interested!



Day 1


Track 1 Track 2
Day 1: FDA’s Quality System Regulation
By - Dan O' Leary, President at Ombu Enterprises, LLC
Wednesday, October 31st 2012, 9 AM to 4 PM PDT
Day 1: An Interactive Workshop on Design Control for Medical Devices Including In Vitro Diagnostic Devices
By - David Lim, Ph.D., RAC, ASQ-CAQ
Wednesday, October 31st 2012, 9 AM to 4 PM PDT

Areas Covered:

The workshop covers the following areas:
  • Laws and regulations in the US
  • Medical device risk classes in the US system
  • The management structure
    • Management responsibility
    • Internal quality audits
    • Documents and records
    • Employee competence
  • Design control
    • Design inputs
    • Design verification and validation
    • Design reviews
  • Production and process controls
    • Automated processes
    • Process validation
    • Inspection, test, and measuring equipment
    • Purchasing
    • Acceptance activities
  • Corrective Action and Preventive Action
    • Implementing corrective action
    • Complaint management
    • Medical device reporting
    • Correction and removals

Areas Covered:

Understanding design control can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.

At this workshop, you will get familiar with regulatory and quality requirements of design control concerning medical devices, active implantable medical devices and in vitro diagnostic medical devices.

The following key areas will be discussed during workshop:

  • Federal Statutes and Regulations Governing Medical Devices in the US
  • Design Controls
    • Introduction
    • Design And Development Planning
    • Design Input
    • Design Output
    • Design Review
    • Design Verification And Validation
    • Design Evaluation Versus Specifications
    • Software Validation
    • Labeling Verification
    • Design Transfer
    • Design Changes
    • Design History File

Agenda

Track 1 Track 2
Morning
9:00 AM - 10:30 AM
  • Laws and regulations in the US
  • Medical device risk classes in the US system
  • The management structure
 [Quality System Regulations; QSRs: cGMP]
  • Federal statutes and regulations
  • Introduction
  • Design And Development Planning
  • Design Input
10:30 AM - 10:40 AM
  • Break
  • Break
10:40 AM - 12:00 Noon
  • Design control
 [Quality System Regulations; QSRs: cGMP]
  • Design Output
  • Design Review
12:00 Noon - 1:00 PM
  • Lunch
  • Lunch
Afternoon
1:00 PM - 2:30 PM
  • Production and process controls
 [Design Control]
  • Design Verification And Validation
  • Design Evaluation Versus Specifications
  • Software Validation
2:30 PM - 2:40 PM
  • Break
  • Break
2:40 PM - 4:00 PM
  • Corrective Action and Preventive Action
 [Design Control]
  • Labeling Verification
  • Design transfer
  • Design changes
  • Design history file (DHF)
  • Device History Record (DHR)
  • Device master record (DMR)



Day 2


Track 1 Track 2
Day 2: The ISO 13485 Quality Management System
By - Dan O' Leary, President at Ombu Enterprises, LLC
Thursday, November 1st 2012, 9 AM to 4 PM PDT
Day 2: An Interactive Workshop on Premarket [510(k)] Notification Submissions
By - David Lim, Ph.D., RAC, ASQ-CAQ
Thursday, November 1st 2012, 9 AM to 4 PM PDT

Areas Covered:

The workshop covers the following areas:
  • The history of ISO 13485
  • Versions of ISO 13485 in the EU and Canada
  • Quality management system and documentation
  • Management responsibility
    • Quality policy and objectives
    • Quality planning
    • Management review
  • Resource management
    • Human resources
    • Infrastructure
  • Product realization
    • Planning
    • Design
    • Production
    • Purchasing
    • Monitoring and measuring devices
  • Improvement
    • Internal quality audits
    • Corrective action and preventive action

Areas Covered:

The following key areas will be discussed during workshop:
  • Federal Statutes and Regulations Governing Medical Devices in the US
  • 510(k) Format and Contents for Various Device Types Including In Vitro Diagnostic Devices
  • What are the applicable statute(s) and regulations?
  • How do you identify and use necessary information for 510(k) filing purposes?
  • How/when do you begin your interaction with the FDA?
  • When do you submit a 510(k)?
  • What happens if we fail to submit the 510(k) when required?
  • What are the available types of 510(k)s and what are the differences in contents for each type of 510(k)?
  • How to determine which 510(k) path is suitable?
  • What factors to consider when choosing a predicate(s)?
  • What are the pros and cons of bundling 510(k)s?
  • What are clinical trial requirements, if applicable?
  • What information/data is needed and how to put all the information together?
  • How to interact before and during the review process upon submission?
  • What to say and how to ask questions without being counter-productive?
  • How do you resolve if differing opinions arise (e.g., IFUs)?
  • What triggers FDA to hold the review process?
  • What to implement for life cycle consideration of your products during post-marketing including labeling control and information dissemination through social media?
  • Review and study of actual 510(k) materials/cases (FDA-cleared and disclosed)
  • What/How to obtain competitors’ 510(k) documents?
  • Much more!

Agenda

Track 1 Track 2
Morning
9:00 AM - 10:30 AM
  • The history of ISO 13485
  • Versions of ISO 13485 in the EU and Canada
  • Quality management system and documentation
  • Management responsibility
  • Overview of 510(k) program, changes and practical advice and guidance
  • 510(k) regulatory requirements
  • How to leverage the resources available to improve 510(k) submission quality
10:30 AM - 10:40 AM
  • Break
  • Break
10:40 AM - 12:00 Noon
  • Resource management
  • Review of relevant and applicable guidance documents and voluntary standards
  • Systematic methods to increase 510(k) submission quality
12:00 Noon - 1:00 PM
  • Lunch
  • Lunch
Afternoon
1:00 PM - 2:30 PM
  • Product realization
 [510(k)s: General Devices]
  • 510(k) submission: contents and format for general devices
  • Quality requirements
  • Submission template reviews
2:30 PM - 2:40 PM
  • Break
  • Break
2:40 PM - 4:00 PM
  • Improvement
 [510(k)s: In Vitro Diagnostic (IVD) Devices]
  • 510(k) submission: contents and format for in vitro diagnostic devices
  • Quality requirements
  • Submission template reviews



Day 3


Track 1 Track 2
Day 3: The Medical Device Directive
By - Dan O' Leary, President at Ombu Enterprises, LLC
Friday, November 2nd 2012, 9 AM to 4 PM PDT
Day 3: An Interactive Workshop on Auditing and FDA Quality Management System (QMS) For Medical Devices Including In Vitro Diagnostic Medical Devices
By - David Lim, Ph.D., RAC, ASQ-CAQ
Friday, November 2nd 2012, 9 AM to 4 PM PDT

Areas Covered:

The workshop covers the following areas:
  • The system of product directives in the EU
    • The new approach
    • The global approach
  • The current version of the MDD and its organization
  • Determining the device class using Annex IX
  • Available conformity assessment paths
    • Effective use of Annex II
    • The role of EN ISO 13485:2012
    • Conformity assessment for Class I devices
  • Essential requirements from Annex I
    • Developing an Essential Requirements Checklist
    • Using harmonized standards for essential requirements
    • Using Clinical Evaluation for essential requirements
  • Clinical Evaluation following Annex X
    • Setting up an initial clinical evaluation
    • Follow-up in the post-production phase
  • MedDev guidance documents
    • Adverse event reporting
    • Other guidance

Areas Covered:

Developing, implementing and following auditing and FDA-compliant QMS can significantly improve various processes in an organization and further expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.

At this workshop, you will get familiar with auditing and QMS pertaining to medical devices, active implantable medical devices and in vitro diagnostic medical devices.

The following key areas will be discussed during workshop:

  • Auditing
  • FDA Quality Management System
  • ISO 14155
  • ISO 14971
  • Various FDA, GHTF and MEDDEV Guidance Documents

Agenda

Track 1 Track 2
Morning
9:00 AM - 10:30 AM
  • The system of product directives in the EU
  • The current version of the MDD and its organization
  • Determining the device class using Annex IX
 [Audit(ing)]
  • Auditing
  • Definitions, principles and procedures
  • Defining, documenting and implementing audit(ing)
  • Maintaining and improving audit(ing)
10:30 AM - 10:40 AM
  • Break
  • Break
10:40 AM - 12:00 Noon
  • Available conformity assessment paths
 [Quality Management System; QMS]
  • FDA Quality management system
  • ISO 14971
  • ISO 14155
  • FDA guidance documents including GHTF and MEDDEV documents
12:00 Noon - 1:00 PM
  • Lunch
  • Lunch
Afternoon
1:00 PM - 2:30 PM
  • Essential requirements from Annex I
 [Quality Management System; QMS]
  • Quality manual
  • Quality requirements, procedures, and processes
2:30 PM - 2:40 PM
  • Break
  • Break
2:40 PM - 4:00 PM
  • Clinical Evaluation following Annex X
  • MedDev guidance documents
 [Quality Management System; QMS]
  • Defining, documenting and implementing QMS
  • Maintaining and improving QMS
  • Lessons learned



Meet Your Instructors

Dan O'Leary
President at Ombu Enterprises, LLC

Dan O'Leary 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, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.


Dr. David Lim
Ph.D., RAC, ASQ-CAQ

Dr. David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com/davidlim), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Currently, Dr. Lim is serving as a faculty at the Regulatory Affairs Professional Society (RAPS) and is an advisor to the Presidents and CEOs of FDA-regulated industry.



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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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Testimonials

What past attendees say:

With the simple approach take by Dan, anyone can learn how to complete a successful MDD implementation.
- Quality Specialist, Rochester Medica

Dan OLeary displayed complete and total Mastery of the subject in this presentation, and in his answers to the questions asked from him.
- Quality Manager, Parker Hannifin Corp

I enjoyed Dan's course very much. The Instructor and materials were excellent and the information he taught will be very helpful to my Company.
- Compliance Coordinator, Diagnostica Stago, Inc.

The MDD subject matter was well illustrated by Den by flow chart and graphics. Please keep offering this subject matter.
- Senior Quality Assurance Engineer, NDI Medical LLC

I have attended webinars from ComplianceOnline but this "Live" one was incredible. This seminar was excellent.
- Quality Engineering Manager, ConvaTec Inc.

I like the medical device directive and topic regarding standards. The design of the presentations was appropriate.
- Director of Research and Development, Metrex Research,LLC

It was well organized event by ComplianceOnline. Communication was good. Presenter was very knowledgeable. Practical application of directives, standards, regulations are very helpful.
- Manager, Quality Assurance, Instrumentation Laboratory

It was well organized event by ComplianceOnline with good subject matter and knowledgeable instructor.
- Director of Operations and Quality, NDI Medical LLC

I appreciate the knowledge given at this seminar. Speaker is very experienced and I found good talent here. I am very happy with first class reference sheet.
- Sr. CAPA Specialist, Johnson & Johnson Vision Care Inc

Knowledgeable speaker with great real life examples and discussions.
- Quality Director, Lifecore Biomedical

It was a well organized seminar. It provides trainees a good understanding about the CA-PA process that complies with regulatory standards.
- QA/RA Representative, ResMed Corp

It was my first conference with ComplianceOnline and experience was good. Love the reference material and flash key.
- Quality Assurance, Beckman Coulter

I think the material and instructor were very knowledgeable and material was excellent. The subject was well chosen and the design of presentation was most appropriate.
- QC, Regulatory affair

My colleague referred me to this event and It was good value for the price. Excellent friendly presenter and coordinator. The amount of interaction between the participants and presenters was ideal. I would also like to recommend this seminar to others.
- Regulatory Manager

I think the instructor were very knowledgeable and material was excellent. Example and templates of PMA & 510k submissions were very useful because it set the framework of how to submit a quality 510k.
- Regulatory Manager

I had very focused reason to attend this seminar: learning more about 510k, classes and requirements. The program was well organized and coordinated by ComplianceOnline.
- Quality Analyst

Dr. Lim is very knowledgeable. The amount of interaction between the participant and presenter was ideal. I would like to refer his trainings to my colleagues.
- QC, Regulatory Affairs

All the topics were well chosen and the design of the presentation was most appropriate. I like the topic “Template for Submission” most. David Lim is an excellent friendly presenter. Overall it was good value for the price with ComplianceOnline.
- Managing Director

ComplianceOnline Seminar offered a lot of valuable and relevant information. Thanks for organizing it very well and professionally. I would like to attend next seminar with in depth classification of medical device.
- Manufacturing Engineer

Speaker was great. The event was well organized and coordinated by ComplianceOnline. I would recommend this to others. Thanks!
- Attorney (Patent)





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