ComplianceOnline

Software Verification and Validation For FDA-Regulated Industries

Instructor: John E Lincoln
Product ID: 701135
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This FDA compliance training will guide you through Software Verification and Validation process in FDA-Regulated Industries.

Description

U.S. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based software V&V. Starting with a Project Validation Plan, evaluating its elements against ISO 14971:2007 hazard analysis / risk management, allows development of meaningful product / process validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time). Two matrices / models simplify regulatory requirements for “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. QMS and 21 CFR Part 11 require yet another approach.

Areas Covered in the seminar:

  • Verification or Validation -- Recent regulatory expectations.
  • The Project Validation Plan.
  • Software Product Validation – how it differs from process / equipment V&V.
  • When and How to use DQ, IQ, OQ, PQ.
  • How to use your Risk Management Tools (per ISO 14971:2007).
  • GAMP guidance.
  • The 11 "must have" elements of software validation.
  • "White box" and/or "black box".
  • Some "real world" test case examples.

Who will benefit:

  • All management levels; project leaders
  • Regulatory affairs
  • Quality systems personnel
  • R&D and engineering staff
  • All charged with new product / pilot development, regulatory submissions, initiating / overseeing company-wide software / V&V planning, using an ISO 14971:2007-based risk-justified approach.
  • CAPA and P&PC personnel desiring to minimize post-production / life cycle and other costly problems.

Instructor Profile

John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.

Follow us :
ComplianceOnline Medical Device Summit 2017

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews Write review

Powerpoint presentation was nice.
- Anonymous

Best Sellers
You Recently Viewed
    Loading