FDA & International Consulting and Training Services
Training Seminars
Contact us at: info@noblitt-rueland.com
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San Francisco Bay
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Golden Gate Bridge
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Dates: October 25-29, 2010 (attend one or more days)
Complaints, MDRs, Recalls & Vigilance for Devices Wednesday, October 27, 2010 **New Course!**Rita Hoffman (Recall Branch Chief, U.S. FDA, CDRH) added as an instructor!
Design Control, the FDA & ISO 2010 Thursday, October 28, 2010
Risk Management, ISO 14971:2007 & FDA Requirements 2010 Friday, October 29, 2010
New this Year! Parallel Course Track---Software Courses offered in parallel at same location
Sofware, the FDA & ISO Tuesday, October 26, 2010
Software Verification & Validation Strategies for Medical Devices Wednesday, October 27, 2010
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: 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, Auditing, and Vigilance are critical for ISO 13485:2003 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 has been revised (2007) and is important for medical device manufacturers to understand.
- 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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