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Expert Resource
specializes in all of these standards.
Our consultants provide comprehensive services including document
development, training, gap assessments, internal auditing, corrective action assistance, implementation and consulting. |
Contact us today to book your seminar registration!
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| Introduction to MedAccred & Root-Cause Corrective Action Seminars |
|
Crash Course in MedAccred Certification |
Expert
Resource offers two half-day seminars, one in the morning and one in
the afternoon, which culminate in a multi-faceted MedAccred
introduction.
Our morning session covers general MedAccred topics, introducing the basics of MedAccred
standards, the roadmap to MedAccred certification, and navigation of MedAccred's eAuditnet portal.
Our afternoon session addresses MedAccred Root Cause and Corrective Action (RCCA) training in 8D Format.
MedAccred's RCCA's are much more detailed than ISO standard CA's
and lack of training in this area is the most common contributor
to Nadcap and MedAccred audit failure. Our training prepares you
for
responding to MedAccred NCR's in a format that is widely required by
many OEM's.
Trainees are encouraged to attend both
sessions to maximize their knowledge base, however sessions are
purchased individually. There are no pre-requisites to attend
either session. Each seminar is
designed for beginners and for those mid-way through implementation,
but can also be helpful as refresher courses for experienced
professionals.
AM Session: Introduction to MedAccred and eAuditnet.com - $150/trainee
8:00 AM to 11:30 AM
Topics Include:
- The origins and mission of MedAccred
- Roles of Primes, Task Groups, Staff
Engineers and Auditors in the accreditation process
- The MedAccred implementation plan, expectations, and responsibilities
- Preparing for the MedAccred Audit
- Best practices and lessons learned from hundreds of ER client Nadcap audits
- Earning merit by performing well in audits to reduce future audit frequency
- How to avoid pitfalls leading to audit failure
- Importance of NCR's and corrective actions
- MedAccred portal (eAuditnet.com) training
- Registering the company and users for eAuditnet.com access
- Downloading public
documents
- Downloading MedAccred audit
checklists
- Using the Qualified Manufacturers List (QML) to search MedAccred certified suppliers
- Scheduling the audit and
confirming the audit contract
- Responding to NCR's
- Reporting of NCR and audit closures
This session includes a PowerPoint presentation with color printed
materials provided free of charge. Materials case studies & lessons learned from
previous ER clients.
PM Session: MedAccred Root Cause & Corrective Action - $150/trainee
1:00 PM to 5:00 PM
Topics Include:
- Defining a proper problem statement
- Containing the non-conformance and implementing temporary correction
- Analyzing the cause(s) of the non-conformance utilizing multiple analytical tools
- Developing and implementing a corrective action plan
- Developing objective evidence to support the corrective action plan
- Validating sustaining corrections and preventing recurrence
- Tips for effective correction action submission to MedAccred for approval
This
session includes a PowerPoint presentation with color printed materials
provided free of charge. Materials include examples of Nadcap
Corrective Action responses, case studies & lessons learned from
previous ER clients, and a work instruction outlining all 19 RCCA steps
which can be adapted to your company.
We host these seminars in our Huntington Beach, CA, USA
office for
groups of 5 to 10 Medical industry professionals. Contact us for dates. We can also
bring this content to your location for groups of up to 20. For more information, contact
us at +1-714-337-3321 or click
here
to send an email.
Funding:
Many of our clients qualify for State
and/or US Federal funding for
training services. This reimburses costs associated with training and
registration. Please contact
us
for more information.
| About the Venue |
Located
in beautiful Southern California, USA, our Huntington Beach office is an
ideal place to attend a seminar. Our training suite overlooks
Orange County and comes fully stocked with amenities to deliver a
comfortable environment where focus and learning can flourish.
We are conveniently within walking distance of The Hotel Huntington Beach,
shopping, nightlife and many popular restaurants. We
are only a short drive away from world-famous attractions like
Disneyland or the beaches of Surf City USA, you can turn your seminar
experience into a destination get-away.
If you are not
familiar with the area and would like some guidance from our local
representatives on lodging or restaurants, please contact us.
| | About Expert Resource | Expert Resource provides MedAccred consulting and training services
MedAccred
is based on Nadcap, the leading worldwide cooperative program of major
companies designed to manage a cost-effective consensus approach to
special processes & products manufacturing and testing specifications and
provide continuous improvement within the aerospace and defense
industries. Only MedAccred takes these principals and applies
them to the medical device industry. MedAccred process and product certification is provided by Performance Review Institute. PRI is the only auditing company approved by the medical device industry to offer official certification audits.
Expert
Resource provides the consulting and training to prepare your company
for successful MedAccred certifications with PRI.
Expert Resource provides: - Introduction to MedAccred training (how
to plan, how to avoid pitfalls, how to earn merit, lessons learned,
fundamental requirements of the program, what to expect)
- Gap assessments with reports including recommendations for how to correct each finding
- Document development (manuals, procedures, work instructions, audit checklists)
- MedAccred special process internal auditing and/or internal auditor training
- NCR (corrective actions) consulting services to prepare a company for the PRI MedAccred audit
- 100% of our clients pass their first attempt at certification!
ER
offers a training course, one for each of the MedAccred Special
Processes, tailored to that special process audit criteria. These
classes are provided on-site tailored to your exact needs to prepare
your company and employees to implement and pass the rigorous MedAccred
audit. Click here to learn more.
Expert Resource: LEADING MEDACCRED EXPERTS Expert Resource is the leading provider of MedAccred and Nadcap consulting services.
100% of our clients (hundreds) pass their first attempt at
certification with PRI. Most of our consultants are spread
throughout the United States, England, and China, but we have also
helped companies in over 10 other countries. Headquartered in
California, we will go anywhere to help you.
Our
clients are very diversified in size, location, and special process
expertise. We have met the needs of the largest OEM's and very small
job shops alike. Our prices are highly competitive and our consultants
are very personable. We specialize in every area of MedAccred and
we guarantee our work. MedAccred
consultants must be (1) technical experts in their fields (ex: Welding,
Plastics, Heat Treating, Sterilization, etc.) and (2) experienced
experts with the MedAccred requirements, many of which are still
developing. Most of our competitors are ISO 9000 consultants with
some vague understanding of Nadcap or MedAccred and very little
experience in those specific fields. Be careful not to use
someone who claims to be able to simply "interpret any standard".
MedAccred requirements are very technical and your consultant should be
a technical expert with decades of experience. The
majority of our MedAccred consultants are Nadcap Lead Auditors, which
means they are the authorities. They work part-time for PRI (the
MedAccred and Nadcap audit certification company) and part-time for
Expert Resource. They are trained by PRI (the authority approved
by all the OEM's and Primes) and have hundreds of audits in their
repertoire. Be sure you are relying on the best because they will
utimately affect not only your certification success but more
importantly they will be modifying how your company
operates. It is critical. Don't leave your company in
the hands of a novice. Our previous history with Nadcap and
MedAccred audits (with clients of various sizes with various special
processes) resulted in 2 or less minor findings per audit, some of
which were flawless audits. Does your MedAccred consultant have a
proven success record?
MedAccred Special Processes / Programs
There are
various MedAccred quality standards for
different products, manufacturing processes and services. Please click
on any of the standards listed below for a more detailed listing.
To view the entire MedAccred
Audit Checklist Listing, please Click
Here. |
David Johnson is the founder of Expert Resource (ER). As the CCO, he
manages all ER consultants and strategizes all ER client projects. He
directs all activities related to consulting, sales, marketing, and
customer relationships. David also provides on-site consulting and
training for multiple initiatives and has been a key expert witness in
litigation cases. He is considered a thought leader in Business
Excellence with a focus on process, employee, and systems integration. |
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