Training Seminars

Contact us at: info@noblitt-rueland.com

Embassy Suites on the Bay	Golden Gate Bridge

New this Year! Concurrent / Simultaneous Courses offered Tues-Fri, at same location, One Course on Monday. (by Training Tracks Listing)

	Complaints, MDRs, & Recalls for Devices 2011 (1) (2)	Monday, October 24, 2011
or	FDA Quality System Regulation (QSR/GMP) & Inspections (1) Software, the FDA & ISO (includes Part 11 update)	Tuesday, October 25, 2011
or	Auditing Quality Systems for FDA & ISO Compliance Software Verification & Validation Strategies 2011	Wednesday, October 26, 2011
or	Risk Management, ISO 14971, and FDA Requirements CE Marking: Medical Devices, IVDs & AIMDs	Thursday, October 27, 2011
or	Design Control, the FDA & ISO IEC 60601-1 Third Edition (3) : Mandatory beginning 2012	Friday, October 28, 2011

(1) Jim Kozick, previous FDA Director of Domestic Investigations for the Los Angeles District Office to be an instructor.

(2) Rita Hoffman, former Recall Branch Chief, U.S. FDA, CDRH, to be an instructor.

(3) Mike Schmidt, convenor of the IEC Committee that wrote IEC 60601-1, 3rd Edition (SC62A/ WG18) to be an instructor.

Live, instructor led training is very effective. This training will be live classroom, person to person training; allowing the attendee to learn valuable insight from the experiences of both the instructors and other companies from their peers. Networking with peers during breaks and lunch will prove to be invaluable to gain insight on how they are handling similar issues or for example; what they experienced during their last FDA inspection.. Instructors will also be available during breaks, lunch and after the programs to answer questions and deal with sensitive issues. In person training allows the attendee to focus on the subject being taught without the distractions of the office, especially phone, e-mail, and personal interruptions.

In-house training program details are very similar to the linked course descriptions, but may vary depending on your specific needs. Call or e-mail for more in-house training details.

Included: Each Registrant will receive a Noblitt & Rueland CD Rom that contains over 100MBs of relevant FDA & International Regulatory Documentation, Guidance, and Regulations. A $499 value!

Considerations for Attending:

• Preparation for your next FDA inspection or ISO audit.
• Reduce your risk of FDA compliance and enforcement actions.
• Learn about FDA investigations & enforcement from a 30 year veteran of FDA and previous District Director of Investigations.
• Learn what FDA expects as a complaint Complaint system.
• Understand what process to follow when considering and implementing a Recall.
• Documented training is required by ISO and FDA GMP/QSR.
• Understand what is a complaint and what should be reported as an MDR and how to report.
• Significant FDA enforcement actions are being taken against non-compliant companies.
• FDA is preforming QSIT Inspections, including Design Control, and warning letters continue to cite Design Control, CAPA, and Management Controls as major areas found to be deficient.
• Prepare for the latest software standards and guidance.
• An increase in 483s, Warning letters, and other enforcement activities is expected.
• How to comply with critical FDA QSR & ISO 13485 requirements.
• Effective internal auditing is critical for successful Quality System compliance.
• Executive managment is legally responsible for quality and is being cited in warning letters and consent decrees.
• Design Control, Risk Management, and Auditing are critical for ISO 13485 compliance in order to maintain your CE Mark.as well as FDA compliance.
• Properly developed and documented software can help speed the 510(k)/PMA and CE Mark approval/clearance process.
• Learn what is required in a Design History File and how to construct.
• Prior inspection preparation is critical for success during the inspection.
• Risk based strategies help streamline submissions and documentation while guiding proper resource allocation..
• How to perform risk and hazard analysis including FMEA & FTA techniques.
• ISO 14971 is important for medical device manufacturers to understand and implement correctly.
• Off-the-shelf (OTS) Software continues to be an area of FDA risk, learn how to comply.
• Civil Penalties being assessed Companies and individuals.
• FDA's Part 11 requirements are not dead. V&V strategies for electronic recordkeeping systems and quality system software will be discussed. Assess your systems now.
• In-house recordkeeping & documentation systems may be at risk now.
• FDA Investigators are inspecting Design Processes and Electronic Recordkeeping Systems.
• Problems found during an inspection may result in re-inspection, increased duration of inspection, and possible enforcement actions. Effective internal audits can prevent this occurance.
• Device & Manufacturing Software Enforcement Increasing.
• Avoidance of delays in Product Submission Approvals/Clearance due to GMP, Risk Analysis, Design Control, or Software issues.
• Reduced liability risk of Product Safety, Design issues & FDA Enforcement.
• Practical understanding for immediate implementation.
• Practical training by experts in their field.

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