FDA & International Consulting and Training Services
Noblitt & Rueland: FDA & GMP, Design Control & Medical Device Software Consulting and Training Services

Training Seminars

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

Laguna Beach!
Disneyland & California Adventure!
So. California Beaches
Disneyland Resort

 

Dates: July 10-14, 2017

Location: Paradise Pier Hotel, Disneyland Resort, Anaheim, California

 

DESIGN CONTROL / RISK / SOFTWARE / SUBMISSION TRACK

Design Control Compliance for FDA & ISO Monday, July 10, 2017
Risk Management, ISO 14971, and FDA Requirements

Tuesday, July 11, 2017

Software Verification & Validation Strategies

Wednesday, July 12, 2017

CE Marking: Medical Devices, IVDs & AIMDs

Thursday, July 13, 2017

510(k) Submissions: How to Get FDA Clearance Fast

Friday, July 14, 2017

REGULATORY / QUALITY TRACK

FDA Quality System Regulation (QSR/GMP) & FDA Inspections (1) Monday, July 10, 2017
Auditing Quality Systems for FDA & ISO Compliance

Tuesday, July 11, 2017

ISO 13485:2016 Towards a Global Quality System

Wednesday, July 12, 2017

Complaint Handling, MDRs, & CAPA for Devices (1)

Thursday, July 13, 2017

Process Validation for Medical Device Compliance (1)

Friday, July 14, 2017

 

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

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

info@noblitt-rueland.com

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

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