Computerized Imaging Device
In-vitro Diagnostic Device

On-site or Virtual Course Listing

On-Site or Virtual Private Group/Company Training

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Date: Your Choice

Location: On-site or Virtual

Who: Your entire company, department, project team, you select

 

DESIGN CONTROL / RISK / SOFTWARE / SUBMISSION TRACK

Design Control Compliance for FDA & ISO

On-site or Virtual
Risk Management, ISO 14971, and FDA Requirements

On-site or Virtual

Software Compliance and V&V for FDA & ISO

On-site or Virtual

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

On-site or Virtual

IEC 60601-1 3rd Edition & Certification Requirements

On-site or Virtual

REGULATORY / QUALITY TRACK

FDA Quality System Regulation (QSR/GMP) & FDA Inspections On-site or Virtual
Auditing Quality Systems for FDA & ISO Compliance

On-site or Virtual

Complaint Handling, MDRs, & CAPA for Devices

On-site or Virtual

ISO 13485:2016 - Towards a Global Quality System

On-site or Virtual

CE Marking: Medical Devices, IVDs

On-site or Virtual

FDA Electronic Recordkeeping & Signatures - 21 CFR Part 11

On-site or Virtual

Process Validation for Medical Device Compliance

On-site or Virtual

 

On-site or Virtual live, instructor led training is very effective. This training will be live training allowing attendees to learn valuable insight from the experiences of the instructors and their peers. Private company training allows for discussion of confidential subjects and deal with sensitive issues. NDAs will be signed upon request.

On-site or Virtual training program details are very similar to the course descriptions provided, but will be customized depending on your specific needs so the topics apply directly to your products and audience. Call or e-mail for more on-site or virtual training details.

On-site or Virtual Training: Click for a list of course offerings.

info@noblitt-rueland.com

Considerations for holding private on-site or virtual training courses:

    • Preparation for your next FDA inspection and ISO audit.
    • Implement and integrate ISO 13485:2016, to include Europe (EU) & Canada, US FDA QSR.
    • Reduce your risk of FDA compliance and enforcement actions.
    • Learn about FDA investigations & enforcement from a 30 year veteran of FDA and Investigations.
    • Preparation for NEW European Medical Device Regulation (MDR) and IVD Regulation
    • Impact of Usability, IEC 62304, & SaMD.
    • Learn what FDA expects for a compliant Complaint Handling system.
    • CAPA receives the most citations in all FDA 483s and Warning Letters..
    • Documented training is required by ISO and FDA GMP/QSR.
    • Cybersecurity risks for medical devices is of great concern to the FDA and manufacturers.
    • Understand what is a complaint and what should be reported as an Medical Device Report (MDR) and how to report.
    • Significant FDA enforcement actions including Consent Decrees 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, including cybersecurity.
    • An increase in 483s, Warning letters, and other enforcement activities is expected.
    • Process Validation, Complaint Handling & MDRs are the most cited non-compliance issues by FDA in Warning Letters.
    • How to comply with critical FDA QSR & ISO 13485 requirements.
    • Effective internal auditing is critical for successful Quality System compliance.
    • Executive managment is legally responsible for quality and is being cited in warning letters and consent decrees.
    • Design Control, Risk Management, and Auditing are critical for ISO 13485 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.
    • NEW ISO 14971:2019 is important for medical device manufacturers to understand and implement correctly.
    • 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.