Noblitt & Rueland, Training Course List, FDA GMP Design Control Software Train

Training Seminars

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


Southern California Beaches	Disneyland

June 16-20, Location: Disneyland Resort; Anaheim, California

July 21-25, Location: Disneyland Resort; Anaheim, California

FDA Quality System Regulation (QSR/GMP) & Inspections 2008 Monday, July 21, 2008

ISO 13485:2003: Implement & Maintain 2008 Tuesday, July 22, 2008

Auditing Quality Systems for FDA & ISO Compliance 2008 Wednesday, July 23, 2008

CE Marking: Medical Devices & IVDs 2008 Thursday, July 24, 2008

510(k) Submissions: Getting to Market 2008 Friday, July 25, 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:

Documented training is required per FDA Quality System Regulation and International Standards (including GHTF & ISO 13485).
Demonstratration of compliance to ISO 13485:2003 is required to sell products in Europe, Canada, and other countries.
FDA is preforming QSIT Inspections, including Design Control, and finding major deficiencies resulting in Warning Letters.
FDA has found numerous CAPA, Design Control, and Management deficiencies during inspections and will continue to focus on these subsystems. Software problems also being cited.
An increase in 483s, Warning letters, and other enforcement activities is expected.
Thorough auditing is the key toward successful Quality System compliance.
Executive managment is legally responsibile for quality.
Design Control and the impact of ISO 13485:2003 and ISO 9001:2000.
What is required in a Design History File and how to construct.
Prior inspection preparation is critical for success.
Corporate Warning Letters are on the rise, corporate management can prevent this from occuring by requiring proper training.
Prepare for the latest software standards and guidance.
Properly developed and documented software can help the 510(k)/PMA and CE Mark approval/clearance process.
Risk based strategies help streamline submissions and documentation while guiding proper resource allocation.
Off-the-shelf (OTS) Software continues to be an area of FDA risk, learn how to comply.
Risk Management and proper ISO 14971 implemenationa is critical for medical device manufacturers.
Global Harmonization Task Force (GHTF) is becoming a major influence internationally with Medical Device Manufacturers.
ISO 13485:2003 causing a major shift in international quality system standard compliance.
Civil Penalties being assessed Companies and individuals.
FDA's Part 11 requirements are still required. Assess your systems now.
In-house recordkeeping & documentation systems may be at risk.
European (EC) Medical Device Directive has been revised.
FDA Investigators are inspecting Design Processes and Electronic Recordkeeping Systems.
Design Control a major requirement of FDA QSR/GMP, ISO 13485:2003 and ISO 9001:2000.
Problems found during an inspection may result in re-inspection, increased duration of inspection, and possible enforcement. Audits can prevent this occurance.
GMP/QSR aligning with ISO 13485 requirements but important differences remain under ISO 13485:2003.
Delays in Product Submission Approvals can be avoided.
Device & Manufacturing Software Enforcement Increasing.