ComplianceOnline Medical Device Summit – 2015
Key Attraction
Innovate novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R & D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations.
Plan for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections.
Build FDA compliant quality management systems. Attend this summit to learn how to develop and implement effective, consistent and reliable quality management systems. Ex-FDA officials and senior company executives will share thoughts and ideas to improve the performance of your current system.
Interact with leading minds in the industry. Attendees will get to network with the prominent decision makers in the industry to exchange ideas, offer thoughts and know-how, and share experiences. Joining this summit will offer a unique opportunity to the attendees to market their offerings and identify new business opportunities.
Deliberate the current state of medical device laws and technology and government oversight. Panel comprising of some of leading medical device experts and veterans will discuss the recent changes to the regulatory environment for the medical device industry and how these changes will impact the approval of new devices. Attendees will gain insight into the current issues and future challenges in the industry. Join this summit to hear from the experts who have extensive experience in all aspects of medical device including R&D, manufacturing quality assurance, approval and commercialization process.
Scale factors for successful medical device commercialization. Discussions with industry veterans through real case studies will help medical researchers, healthcare professionals, industrialists and entrepreneurs’ better understand the criteria’s for successful commercialization of medical devices. This summit also offers numerous opportunities for medical device companies and suppliers to showcase their products and services to potential customers, generating leads and growing their businesses.
Enhance risk management strategies for the safe, effective and efficient use of medical devices. Medical device professionals will join together to share their knowledge and best practices for implementing good risk management principles within the industry. Attending this summit will help you to develop a robust and integrated risk management plan to improve quality management system.
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Full day In-person Seminar: Harmonized Tariff Schedule and Schedule B
This full-day seminar will provide comprehensive information on how to classify products under the Harmonized Tariff Schedule (HTS) and Schedule B using the General Rules of Interpretation.
Over 180 countries engaged in international trade use the HTS. Schedule B is used solely for exports from the United States.
The seminar will cover the differences in the HTS vs. Schedule B with easy to understand examples and workshops covering many different products. This training will also aid departments involved in determining if their goods qualify for duty free rates under the North America Free Trade Agreement. The correct harmonized tariff numbers are essential for properly completing the NAFTA Certificate of Origin for qualified goods.
Location:
Doubletree Hotel Anaheim/Orange County
100 The City Drive | Orange, CA 92868-3204
Areas Covered:
- History and Legal Text of the HTS
- Structure of the Harmonized System
- Differences between HTS and Schedule B
- General Rules of Interpretation
- Additional U.S. Rule of Interpretation
- General Notes (summary of trade agreements and more)
- Classification Rulings
- Workshops (covering many different products)
Who will benefit
- Importers
- Exporters
- Sales and Marketing Managers
- Purchasing Managers
- Freight Forwarders / Customhouse Brokers
- Compliance personnel classifying goods under the HTS
- Qualifying goods under free trade agreements, ex. NAFTA and others.
- Trade Consultants
- Attorneys and Legal Staff
Meet Your Instructor:
Jan Seal, is a Management Consultant on International Trade and a Licensed Customhouse Broker with over 35 years of experience in imports and exports. Ms. Seal is a frequent speaker/instructor at nation-wide seminars for international companies located around the world and international trade organizations. She also is a consultant for medium to multi-national companies on trade compliance. She has taught courses for Import Specialists at the National Customs Academy.
She is the author of eight books on various international trade topics.
She received her BA Degree from California State University at Fullerton with a year of post-graduate work in Education at the University of California, Riverside. She received her MBA at California State University, Dominguez Hills, and is a member of Delta Mu Delta National Honor Society in Business Administration.
Clear as Mud: Obtaining & Marketing your 510(K) with Today’s FDA
Course Description:
An interactive workshop to ensure you understand how to obtain a 510(k) in today’s environment at FDA.
Knowing how to get your application through FDA quickly can save millions of dollars in unnecessary investment burn. Mr. DuVal, a national authority on the 510(k) program is in Silver Spring, Md. at FDA nearly twice a month negotiating 510(k) issues for his clients. Mr. DuVal will teach you the tips and tricks of the trade that he has learned in the trenches with FDA. Both attorneys also participate in the national dialogue on the proposed changes to the 510(k) program. Mr. Gardner will focus on pre-clearance/pre-approval communication, as well as the promotional issues companies face once they are on the market.
Practical questions answered at the workshop:
- How do you obtain a 510(k) in today’s environment at FDA? How do you position your 510(k) submission? How do you fashion the intended use statement and argue the technological characteristics are the same and do not raise “new types” of questions of safety and effectiveness?
- What to do when things do not go right? How do you answer Additional Information (AI) letters, when and how to push back meetings with FDA, whom to include and how to prepare the appellate process at CDRH, what avenues to pursue and when?
- When you get your 510(k), how do you market a product with a general intended use statement when your product can be used in many specific indications/patient populations? What communication and dissemination strategies should you adopt? What to do when FDA disagrees with your promotional positioning?
A proper understanding of the 510(k) process from start to finish is critical to avoid problems. In addition, an understanding of FDA-compliant promotional strategies is very essential for you and your company to succeed in this complex regulatory environment.
ComplianceOnline has partnered with nationally renowned law firm DuVal & Associates to bring this workshop containing 6 hours training plus 1.5 hours of Q & A program and featuring nationally known regulatory attorneys Mark DuVal and Mark Gardner, who have worked on hundreds of 510(k)s, de novo submissions, PMAs and combination products. They will offer insights on the 510(k) process from submission writing and FDA meetings to commercialization strategies for your device.
Conference Details:
Friday, October 21, 2011, 9 AM to 5 PM
The Boston Park Plaza Hotel & Towers
50 Park Plaza at Arlington Street
Boston, MA 02116 – 3912
Who will benefit?
- CEOs
- VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs
- Regulatory affairs
- Attorneys
- Quality Assurance
- Risk Managers
- Risk Management team members
- Quality Engineering
- Market Research
- Clinical
- MDR Reporters
- Production
- Engineering & R&D
- Professionals involved with premarket notification to the FDA
- R&D personnel involved in approving the design of medical devices
- Sales personnel involved in approving the marketing of medical devices
Meet Your Instructor
Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.
Mark Gardner, M.B.A., J.D., is an Associate Attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice focuses on compliance (federal and state anti-fraud and abuse laws, anti-kickback analysis, HIPAA & HITECH, and development of training and compliance programs) and promotion (appropriate and lawful off-label dissemination procedures, sales contracts, labeling and advertising review, continuing medical education programs (CME), product launch campaigns, pre-approval communications programs, direct-to-consumer (DTC) advertising, and domestic and international web strategy). Prior to joining the firm, Mark worked in the medical device industry for 10 years as a marketer in product management and previously in sales roles. While working at ev3, Celleration, and Medtox Mark focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications.
2-day In-person Seminar: Computer System Validation – Reduce Costs and Avoid 483s
Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential.
This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.Attendees learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
The instructor addresses the latest computer system industry standards for data security, data transfer,and audit trails. Students see how 21 CFR Part 11, the FDA regulation pertaining to use of electronic records and signatures, and the HIPAA electronic security regulations for patient medical records fit into the validation process. Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline SOP authoring, revision, review, and approval.
This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.
Location:
Location1: Philadelphia, PA, Oct 20-21, 2011
The Ritz-Carlton, Philadelphia Hotel
Ten Avenue of the Arts
Philadelphia, Pennsylvania 19102
Ph: 215 523-8000
Hotel catering manager Direct: 215-523-8256
Name: Susan Brinch
Email: Susan.Brinch@ritzcarlton.com
Location2: San Francisco, CA, Feb 2-3, 2012
venue will be announced shortly
Course Objectives:
- Implement a computer system to gain maximum productivity and reduce cost by as much as two thirds
- Quickly cross train workers and see how to make use of temporary workers and outsourcing to promote growth and reduce costs
- “Right size” change control methods that allows quick and safe system evolution
- Minimize the validation documentation to reduce costs without increasing regulatory or business risk
- Write test cases that trace to elements of risk management
- Protect intellectual property and keep electronic records safe
Who will benefit
This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.
- Regulatory Affairs
- QA/ QC
- IT/IS
- Software Managers
- Project Managers
- Software vendors and suppliers
Meet Your Instructor
David Nettleton, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.
He has completed more than 196 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation – Ten easy Steps (Davis Horwood International and PDA – www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.
The Lean Machine™ – Quality Management Software
The Lean Machine™ is Quality Management Software
designed specifically for companies with fewer than
500 employees. With it, you can ensure:
- You comply with international quality system standards such as ISO 9001, ISO 13485 and many others
- Your employee efforts in quality management will be focused and efficient
- Nothing falls through the cracks
The Lean Machine™ integrates a full spectrum of time-tested modules, delivering a flexible system that is simple, cost-effective, quick to implement and quick to adopt. Through a continuous practice of incorporating user suggestions, The Lean Machine™ will either already have just the features you need, or will make the required adjustments fast.
Rapid updates + user involvement = Quality Management Software at an off-the-shelf price that contains the collective wisdom and experience of managers from all over the world, with features you can customize for your business.
The Lean Machine’s flawless success rate has proven that working together, we can help move your company forward faster, better – and do it for less with quality management software that is built to compete, not just comply.
For More Details:
Compliance Consulting
ComplianceOnline, a consulting organization helps companies in achieving quality and compliance objectives with help of its pool of 300 elite compliance consultants offering consulting services to organizations – both large and small. Our experts are located across the globe and possess a wide range of experience, working with large and small organizations in their compliance or quality departments. Together, their experience covers the comprehensive set of regulations and quality standards from several industries including pharmaceuticals, medical devices, high tech manufacturing, banking and financial services, and food industry.
For More Details:
http://complianceonline.com/ecommerce/control/compliance_consulting
CAPA(Corrective and Preventive Action)
Corrective and Preventive Action or commonly known as CAPA is a concept within Good Manufacturing Practice (GMP). Objective of CAPA is to perform a systematic investigation of discrepancies in order to prevent them from resurfacing. Systematic investigation of the failure incident helps to track down the effectiveness and efficiency of implemented CAPA.
Corrective and Preventive Action
CAPA is a key element to QMS which is focused to continual improvement and incessant customer satisfaction. CA or the corrective action, on one hand, is intended to find out the root cause of nonconformance while on the other hand, PA or the preventive action is chalking out a plan to prevent a problem from surfacing again in the future.
CAPA: Corrective Action – the ISO 9001 Standard Requirements
Corrective action is meant to identify the root cause for the Nonconformity. Once the root cause is identified, motto of the company should be initiating an action to eliminate it: The corrective action. For implementation of successful corrective action, the stepping stone is an efficient documentation as only the documentation will help you to verify whether your corrective action was enough, effective and fruitful.
CAPA: Preventive action – the ISO 9001 Standard requirements
Preventive action is performed to eliminate potential event that can create nonconformity. While talking about preventive action, we must remember that the nonconformity has not taken place yet and it is a preventive action of identifying and eliminating the cause of nonconformity.
For effective implementation of preventive action, documentation of the process and steps is a must. Only a proper documentation will help you track the effectiveness and sufficiency of the preventive action process.
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