FDA New Draft Guidance on (Software) and Device Changes 510k

  • 150.00 Dollar US$
  • Published date: August 13, 2018
    • Fremont, California, United States

Overview:
A 510(k) is a premarket submission made to FDA to demonstrate that the

device to be marketed is at least as safe and effective, that is,

substantially equivalent, to a legally marketed device (21 CFR 807.92(a)

(3)) that is not subject to PMA.

Why should you Attend:
This includes any major change or modification to the intended use of the

device that could have an impact on patient safety and effectiveness. After

attending this webinar, you will be able to better navigate the processes

required to determine how to manage software and device changes in an

FDA-compliant manner.

Areas Covered in the Session:
Medical Device changes
Software Application changes for software used in conjunction with

medical devices
FDA Guidance Documents
FDA Enforcement
New 510(k) submission
Substantial Equivalence

Who Will Benefit:
Information Technology (IT) Analysts
IT Developers
IT Support Staff
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Quality Managers, Chemists and Microbiologists
Compliance Managers and Auditors
Lab Managers and Analysts

Speaker Profile:
Carolyn (McKillop) Troiano has more than 35 years of experience in the

tobacco, pharmaceutical, medical device and other FDA-regulated

industries. She has worked directly, or on a consulting basis, for many of

the larger pharmaceutical and tobacco companies in the US and Europe,

developing and executing compliance strategies and programs. Carolyn is

currently active in the Association of Information Technology Professionals

(AITP), and Project Management Institute (PMI) chapters in the Richmond,

VA area.

Event Fee: One Dial-in One Attendee Price: US $290.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Result 0 votes
Compliance4All
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Good Documentation Guideline (Chapter 1029 USP)

    Good Documentation Guideline (Chapter 1029 USP)

    Quality Control, Safety & Security Fremont (California) August 13, 2018 150.00 Dollar US$

    Overview: Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system. Why should you Attend: GDP is part of GMP and if you know it by heart, it preve...

  • cGMPs in the Quality Control Laboratory (Medical 2018)

    cGMPs in the Quality Control Laboratory (Medical 2018)

    Quality Control, Safety & Security Fremont (California) July 11, 2018 150.00 Dollar US$

    Overview: In this webinar we will apply one aspect of this proactive approach, the review regulatory requirements and analysis of 483 and Warning Letter observations to determine if similar observations could be made in the participants facility and ...

  • Compliance for Electronic Records and Signatures (21 CFR Part 11)

    Compliance for Electronic Records and Signatures (21 CFR Part 11)

    Quality Control, Safety & Security Fremont (California) July 11, 2018 150.00 Dollar US$

    Overview: Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, an...