Training Seminars

Contact us at: info@noblitt-rueland.com

Excalibur Hotel & Casino	Las Vegas, Nevada

FDA Quality System Regulation (QSR/GMP) & Inspections 2008 Monday, October 20, 2008

Auditing Quality Systems for FDA & ISO Compliance 2008 Tuesday, October 21, 2008

Design Control, the FDA & ISO 2008 Wednesday, October 22, 2008

Risk Management, ISO 14971:2007 & FDA Requirements 2008 Thursday, October 23, 2008

Software Verification & Validation Strategies 2008 Friday, October 24, 2008

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.
• Documented training is required by ISO and FDA GMP/QSR.
• 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.
• An increase in 483s, Warning letters, and other enforcement activities is expected.
• How to comply with critical FDA QSR & ISO 13485: 2003 requirements.
• Effective internal auditing is critical for successful Quality System compliance.
• Executive managment is legally responsibile for quality and is being cited in warning letters and consent decrees.
• Design Control, Risk Management, Software V&V are also critical for ISO 13485:2003 compliance in order to maintain your CE Mark.as well as FDA compliance.
• Learn what is required in a Design History File and how to construct.
• Prior inspection preparation is critical for success during the inspection.
• Prepare for the latest software standards and guidance.
• Properly executed and documented software V&V is critical for obtaining 510(k)/PMA and CE Mark approval or clearance.
• Risk based strategies help streamline submissions and documentation while guiding proper resource allocation.
• Off-the-shelf (OTS) and 3rd Party Software continues to be an area of FDA risk, learn how to comply.
• How to perform risk and hazard analysis including FMEA & FTA techniques.
• ISO 14971 has been revised (2007) and is important for medical device manufacturers to understand.
• 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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