— June & July 2006 — Disneyland Resort, Anaheim CA USA
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April 11, 2006 — /MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM)/ — IRVINE Calif. — Noblitt & Rueland today announced its regulatory seminar schedule for June & July 2006, with all events to be held at the Disneyland Resort in Anaheim CA USA. Topics that have become top priority for FDA reviewers and compliance inspectors will be covered.
FOCUS:
Recent regulatory issues and enforcement issues may impact you and your company now and in the near future. Noblitt & Rueland’s annual series of important regulatory training programs will help protect you and your company from severe regulatory enforcement action.
International firms or colleagues may want to take advantage of the favorable currency exchange rates, to learn US FDA requirements and issues first hand.
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DOWNLOAD A SEMINAR BROCHURE:
http://sacserv.com/tracking.jsp?linkid=32532&subid=3838834&campid=147707&type=0
TO REGISTER:
http://sacserv.com/tracking.jsp?linkid=32533&subid=3838834&campid=147707&type=0
JUNE COURSE SCHEDULE:
— June 19 2006; Mon — Design Control, FDA & ISO
— June 20 2006; Tue — Risk Management, ISO 14971 & FDA Requirements
— June 21 2006; Wed — Software, FDA & ISO
— June 22 2006; Thu — Software Verification & Validation Strategies
— June 23 2006; Fri — IEC 60601-1 3rd Edition, Just Released
JULY COURSE SCHEDULE:
— July 17 2006; Mon — FDA Quality System Regulation (QSR/GMP) & Inspections
— July 18 2006; Tue — ISO 13485:2003 Understand & Implement
— July 19 2006; Wed — Auditing Quality Systems for FDA & ISO Compliance
— July 20 2006; Thu — CE Marking: Medical Devices & IVDs
— July 21 2006; Fri — 510(k) Submissions: Getting to Market
VENUE:
— Disneyland Resort, Anaheim CA USA.
— Come enjoy Disneyland’s 50th Anniversary Celebration, with special discounted room rates.
— Special course discounts, including multiple attendee discounts, are available.
— NOTE: Early registration discount and reserved room block deadlines are ending soon.
CRITICAL ISSUE HIGHLIGHTS: FDA & ISO MEDICAL DEVICE HOT TOPICS:
— RISK MANAGEMENT & ISO 14971 HAVE BECOME ESSENTIAL TO THE MEDICAL INDUSTRY. As a result, ISO 14971 has become the de facto standard by which to comply. This course will discuss risk techniques, ISO 14971, and how to comply with risk requirements of the FDA and other regulatory groups worldwide. This course will describe details of what to do, how to conduct risk and hazard analysis, and how to comply.
— The GLOBAL HARMONIZATION TASK FORCE has released a final guidance document on Implementation of Risk Assessment Management Within a Quality Management System.
— DESIGN CONTROL CONTINUES TO BE A MAJOR FOCUS DURING FDA QUALITY SYSTEM INSPECTIONS. Warning Letters continue to site design control issues found during FDA Quality System/GMP inspections. Many companies experience problems effectively implementing design control.
— IEC 60601-1 3RD EDITION was recently released. It is important to understand how this new edition may impact medical electrical equipment. Without complying with changes in this new edition, your ability to sell products may be adversely impacted.
— FDA has published a SOFTWARE GUIDANCE DOCUMENT for use by FDA reviewers and manufacturers. Understanding the impact of this guidance on manufacturers and designers of medical devices is vitally important.
— SOFTWARE VERIFICATION & VALIDATION USING A RISK-BASED APPROACH IS CRITICAL FOR COMPLIANCE. Companies can demonstrate software compliance in product submissions, such as 510(k), PMA, IDE and CE Mark submissions; Part 11 compliance in Quality Systems; and for manufacturing systems.
— ISO 13485:2003 DEADLINE IS RAPIDLY APPROACHING. By July 15 2006 Medical Device manufacturers must have implemented or transitioned to ISO 13485:2003, in order to continue to sell products in Europe and other parts of the world. The Canadian deadline has already passed. Properly implemented, ISO 13485:2003 can co-exist easily and efficiently with FDA QSR compliant quality systems. If you have already implemented ISO 13485:2003, prepare now for your renewal inspection by being able to show proper documented training. If you need in-house training before this course offering please contact us for a quotation.
— THE REQUIREMENT FOR INTERNAL AUDITING WHEN PERFORMED EFFECTIVELY HAS SAVED MANY COMPANIES BOTH ENFORCEMENT HEADACHES & PENALTIES. Companies have avoided negative competitive and investor relations by finding and correcting deficiencies prior to FDA inspections. These corrections have prevented FDA enforcement actions and Warning Letters from being issued, published on the Internet, and being available to competitors for distribution to customers. In addition, many companies have found that investors become nervous when FDA enforcement actions occur. Obviously, many times the firms experience a negative impact to their stock price or funding.
— FDA ESTABLISHMENT INSPECTION RULES PROVIDE MANUFACTURERS WITH AN OPTION FOR INSPECTIONS TO BE CONDUCTED BY ACCREDITED 3RD PARTIES.
— CAPA, DESIGN CONTROL & MANAGEMENT RESPONSIBILITY REMAIN AS TOP WARNING LETTER CITATIONS & INSPECTION OBSERVATIONS.
— SEVERITY OF ENFORCEMENT PENALTIES HAS INCREASED; REPEAT OFFENDERS & MANAGEMENT BEWARE.
— ENFORCEMENT IS VERY COSTLY. Recent judgments and enforcement by the FDA confirm that companies and their management must ensure that they are compliant with the Quality System (QS/GMP) regulations. Recent enforcement actions resulting from GMP/QS regulation violations penalties included a $100 million and $500 million fine, injunctions to stop manufacturing due to QSR and design control issues, international firms receiving import detention, etc.
— WARNING LETTERS ARE BEING CHECKED TO BUILD CASES AGAINST FIRMS. Be aware that the FDA’s Office of Chief Counsel (OCC) is continuing to review all FDA Warning Letters prior to issuance, in an effort to provide consistency and case building in the event of an enforcement action. The better trained your company and employees are, the less likely are Warning Letter citations and risk further enforcement actions.
DOWNLOAD A PROGRAM BROCHURE:
http://sacserv.com/tracking.jsp?linkid=32534&subid=3838834&campid=147707&type=0
COURSE-SPECIFIC INFORMATION INCLUDES A BRIEF OUTLINE FOR EACH COURSE:
http://sacserv.com/tracking.jsp?linkid=32535&subid=3838834&campid=147707&type=0
REGISTER ONLINE AT:
http://sacserv.com/tracking.jsp?linkid=32536&subid=3838834&campid=147707&type=0
or by fax at 714-258-3990.
FOR ADDITIONAL INFORMATION:
http://sacserv.com/tracking.jsp?linkid=32537&subid=3838834&campid=147707&type=0
Printed brochures and registration is also available by phone at 714-258-4649 or 888-892-4664 (in the US and Canada).
NOTE: When you register for any of these courses and mention (either verbally or in the comments section online) that you are responding to this press release, we will send you your choice of either an updated Noblitt & Rueland CD ROM containing a compilation of the most recent FDA/International regulations and guidelines pertaining to these courses (retail $499 value), or the actual FDA’s Investigator’s Training CD-ROM for learning about the Quality System Inspection Technique (QSIT).
For immediate response, please send your message to [email protected] and do not reply to this e-mail, or contact us by phone at 714-258-4649, or fax at 714-258-3990.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Brent Noblitt
Senior Partner
Noblitt & Rueland
5405 Alton Pkwy 5A #530
Irvine CA 92604-3718
714-258-4646 phone
714-258-3990 fax
[email protected]