Medical Device Single Audit Program (MDSAP) – Implementation

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2-Day In-Person Seminar from COMPLIANCE TRAININGS (Code – SEM9014)

Medical Device Single Audit Program (MDSAP) – Implementation

RAI CHOUWDHARY

The KPI System

March 12 – 13, 2018

Toronto, ON, Canada

 

Why You Should AttendAgendaSpeakerPricingVenue

Medical Device Single Audit Program – aka MDSAP is here and accepted (albeit in different ways) in selected countries / jurisdictions. However – there is much to understand / think about what it is, how will it work, which types of companies should go for it, what types of audits will it entail, how different countries are layering their additional requirements within MDSAP…etc. It can be overwhelming; but help is here.

This 2-day interactive workshop will answer many questions and take you beyond training programs offered by Auditing Organizations. You will increase your awareness of the elements, processes, and sequencing of events associated with MDSAP. Most importantly, “your” specific questions will be answered. .


Seminar Fee Includes:
Training
Lunch
AM-PM Tea/Coffee
Seminar Materials
USB with Presentation Handout
Attendance Certificate
Networking Sessions
$100 Gift Voucher for next seminar

Here Are Your Takeaways:

 

Using individual and / or group interactive exercises, Increase your ability to:
  • Face the MDSAP audit
  • Prepare your organization’s QMS and SOPs
  • Build commitment among various functions within your company
  • Get your staff, management, and leadership on board as the organization prepares for MDSAP
  • Decide on a “sensible and practical” scope for the audit
  • Identify gaps within your organization vs. requirements of MDSAP
  • Understand / interpret the regulatory terminology from the countries that are part of this program

Who Should Attend :

  • Quality Departments
  • Regulatory Affairs Departments
  • Engineering Departments
  • Manufacturing Departments
  • Production Departments
  • Design Development Professionals
  • Scientists
  • Internal Auditors
  • Quality Engineers
  • Quality Auditors
  • Compliance Departments
  • Research and Development Departments
  • Process Owners

DAY 1 (8 AM – 5.30 PM):

Registration Process – (8:00 AM – 8:30 AM)

MDSAP – An Overview

  • MDSAP goals, timelines, resources, and intended outcomes
  • Awareness of MDSAP elements
  • Evaluate impact on medical device manufacturers
  • Organizational readiness assessment
  • Parties involved in MDSAP
  • Roles and Responsibilities

MDSAP vs Quality Management System Audits

  • Comparisons
  • Benefits and Challenges

Process Approach and Risk

  • MDSAP Processes, Outcomes, and Tasks
  • Integration of Risk-Based Thinking

Structure and Scope of the MDSAP Audits

  • Steps in the MDSAP audit
  • Timing of such steps
  • Processess audited within the Program
  • Regulatory requirements covered during the audit (21 CFR 820, MHLW, ANVISA, TGA, HC, and others as applicable)

DAY 2 (7.30 AM – 4.30 PM):

 

Country-Specific Requirements

  • Additional regulatory requirements in the MDSAP scope
  • Processes and tasks with additional country-specific requirements
  • Tools that map MDSAP processes
  • References of country-specific deviations to ISO 13485

Nonconformity

  • Characteristics of well-written and poorly written nonconformities
  • The Grading Matrix
  • Grading Escalation Rules
  • Practice nonconformity grading using the MDSAP scale

Internal Audit Considerations

  • Requirements of an effective internal auditing program
  • Aligning the internal audit program to the MDSAP model

MDSAP Reports and Format

  • Report Writing, Certification and Submission to Regulators
  • How regulatory authorities utilize MDSAP audit reports

Trends and Next Steps

  • MDSAP trends and the program’s current status
  • Identifying next steps and what future holds

Rai Chowdhary

CEO and Founder of The KPI System


Rai is ASQ Certified – Quality Auditor, Quality Engineer, Quality Manager / Operations Excellence, and Six Sigma Black Belt. His credentials include Mechanical Eng., Production Eng., and a Masters in Materials Science.

He is a sought-after mentor, and an award-winning presenter. His MDSAP workshops have received top scores, and excellent feedback because of his ability to create a great learning environment, and convey complex information in easy to understand manner.

With 30+ years of business and technical expertise gained from diverse industries, world leading companies have found him to be an invaluable resource for coaching / mentoring / training their staff. A sample list of the large and small firms that have benefited include: Reckitt Benckiser, Edwards Life Sciences, Abbott, Glaxo, Sulzer, DuPont, BSI, DJO Surgical, Varian, Amedica, Maxtec, Dell, and many others.

Rai is also an author, and contributes to standards development.

 

PRICING OPTIONS
For Single Delegate – $ 1200 (Save $ 300 on Early Bird Discount)
Regular Price – $ 1500

Group of 3 Delegates – Get 10% Discount (Save $ 1260)
Group of 5 Delegates – Get 20% Discount (Save $ 2700)

EARLY BIRD OFFERS CLOSES ON FEBRUARY 23, 2018
 
 
** All Prices are inclusive of HST
 
Early bird seats are limited and based on first-come, first-serve..(Only 5 Remaining)
 

For discounts on multiple registrations, contact customer care at +1-416-915-4458

 
REGISTER NOW


Payment Options

Register Online:

  • Make Secure Payment using Credit Card
  • Click on Register Now, and you will be redirected to Payment Options page.
  • Please choose your option (No. of delegates) from the drop down and click on Add to basket
  • Click on Proceed to Checkout on the Cart Page, and complete the registration.
  • Once the payment is completed, you will be receiving a Form to fill up the Delegates Information
  • An electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date.
  • Please bring the respective passes to the event venue.


Pay by Wire:

  • Please contact our support to assist you with registration by Wire
  • Support Number: +1-416-915-4458
  • E-mail: info@webinarcompliance.com

By Check:

  • Pay your check to (payee name) “FutureCorp Consulting Inc” our parent company
  • Please send the Scanned copy of the check to info@webinarcompliance.com
  • Mail the check to:
    FutureCorp Consulting Inc
    5969, Candlebrook Ct.,
    Mississauga, ON L5V 2V5,
    Canada
  • Once we receive the check, you will be receiving a Form to fill up the Delegates Information
  • After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.

Toronto, ON, Canada

(Venue to be announced shortly)
March 12 – 13, 2018
  

Call for Assistance: +1-416-915-4458

  

REGISTER NOW