This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"

1. Medical Device Changes and the 510(k)
Wednesday, September 22, 2014 | 10:00 AM PDT | 01:00 PM EDT | Duration : 90 Minutes | Register Now
This webinar will provide valuable guidance to regulated
companies in development and implementation of formal,
defined, documented methods for analysis of product changes
and when to file a new 510(k). Consideration of the U.S . FDAs
current K-97-1 Memo or guidance document on "510(k) Device
Modifications"
Control of medical device changes and a current 510(k) are big
issues in recent FDA studies. Companies are held fully
responsible for deciding when a new 510(k) filing is warranted.
Often this is a difficult decision process. Effective change control
and the power of current risk management tools must be a major
part of such an analysis. The U.S. FDA has its current K-97-1
Memorandum (they recently pulled their proposed new draft
Guidance Document, "510(k) Device
Instructor:
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John E. Lincoln
John E. Lincoln is a medical device and
regulatory affairs consultant. He has
helped companies to implement or
modify their GMP systems and
procedures, product risk
management, U.S. FDA responses. In
addition, he has successfully

2. Modifications: Deciding When to Submit a 510(k) for a Change
to an Existing Device"). K97-1 provides a tool to assist in device
and new 510(k) or change analysis. The addition of such simple
tools will assist companies in implementing formal, documented,
repeatable methods with defensible rationale for their decisions
on when changes trigger the need for a new 510(k) submission.
The K97-1 analysis is the preferable tool to work with a
companys change control system to document the need to file,
or the rationale for not submitting a 510(k). It is recommended
as the preferred method for documentation of each change in
a device during its lifecycle. Provides for a Step-by-step analysis:
Manufacturing, Labeling, Tech or Performance, and or Materials
Changes. Consideration of which of the three major 510(k)
formats should be used: Traditional, Special or Abbreviated.
Areas Covered in the Session :
This webinar will provide valuable assistance to all regulated
companies performing and documenting meaningful, results
driven 510(k) or change analysis activities, based on the FDAs
current Guidance on 510(k) Device Modifications. This session
will cover:
Deciding When to Submit a 510(k) for a Change to an
Existing Device, K97-1
How to provide tools to document such decisions
It will discuss how companies can best document their
decisions -- whether or not a new 510(k) filing is
warranted
How to structure a decision matrix to document change
decisions
How to evaluate changes that could trigger the "Tipping
designed, written and run all types of
process, equipment and software
qualifications or validations, which
have 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 or design
control, 510(k) submissions, risk
management per ISO 14971, and
projects; with over 28 years of
experience in the FDA-regulated
medical products industry - working
with start-ups to Fortune 100
companies, including Abbott
Laboratories, Hospira, Tyco or
Mallinckrodt. He is a graduate of UCLA.
Upcoming Webinars:
How to Implement HIPAA
Requirements in GxP Regulated
Establishments
FDA Adverse Event Reporting for
Drugs and Medical Devices
Available Recorded Webinars:
Robust Verification and Validation
Navigating your way through ISO
13485
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3. Point"
Who makes the decisions and how to defend them
How to implement formal methods with documented,
and defensible rationale
Preparing for further 510(k) changes in the future
Who Will Benefit:
This webinar is a must for companies in the Medical Device and
combination products fields. The employees who will benefit
include:
Research & Development
Engineering Staff
Quality Assurance Regulatory
Affairs Lean & Six Sigma staff
New Product Development
Marketing
Mid-level and Senior Management
Project Leaders
Consultants
Register Now
About Compliance Trainings:
Medical Devices Designing w ith
Cleanliness in Mind
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Management in the Medical Device
Industry
HIPAA Privacy &Security - Business
Associate Training
Assessing FDAs Proposed Changes to
the 510(k) Process
How to Manage a Product Medical
Device Recall Efficiently and Effectively
21 CFR Part 820 - Quality System
Regulation - Applying Principles of
Lean Documents and Lean
Configuration
Good Practices for FDA 510(k):
Content and Format
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Design Inputs - Design Outputs
Traceability Matrix - Principles of Lean
Documents and Lean Configuration
Acceptance Activities in FDA QSR
Implementing an Internal Audit
Program of QMA, Persisting to ISO
13485 and 21 CFR Part 820
Medical OEM Design Control Audit:

4. It would be really nice if you can share this mail to all your colleagues who can get benefit from this training.
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