FDA & International Consulting and Training Services

Training Seminars

Download a brochure or e-mail us and we will send you a printed brochure.


San Francisco Bay	Golden Gate Bridge

Dates: October 26-30, 2009 (attend one or more days)

Location: Embassy Suites on the Bay; Burlingame, California

FDA Quality System Regulation (QSR/GMP) & Inspections 2009 Monday, October 26, 2009

Auditing Quality Systems for FDA & ISO Compliance 2009 Tuesday, October 27, 2009

Design Control, the FDA & ISO 2009 Wednesday, October 28, 2009

Risk Management, ISO 14971:2007 & FDA Requirements 2009 Thursday, October 29, 2009

Software Verification & Validation Strategies 2009 Friday, October 30, 2009

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.

In-house Training: Click for a list of course offerings.

info@fdaconsulting.com

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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