Reviewing the most significant changes affecting medical device standards and guidance documents, Understanding the MDSAP (goals and strategy), Analyzing the MDSAP main differences with standard auditing, Understanding grading of MDSAP non-conformances

1. 2-day In-person Seminar:
Knowledge, a Way Forward…
Implementing MDSAP (Medical Device Single Audit Program)
for Compliance Success
Boston, MA
May 4th & 5th, 2017
9:00 AM to 6:00 PM
David R. Dills
Price: $1,295.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price
Overview :
Global
CompliancePanel
David R. Dills, Global Regulatory Affairs &
Compliance Consultant currently provides regulatory affairs and
compliance consultative services for early-stage and established Class
I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical
manufacturers on the global landscape, and has an accomplished
record with more than 27 years of experience in the areas of
Regulatory Affairs, Compliance and Quality Systems. He has been
previously employed, with increasing responsibilities by device
manufacturers and consultancies, including a globally recognized CRO
and has worked directly with manufacturers engaged in compliance
remediation activities involving consent decrees, CIA's, warning letters,
and customer generated compliance events, conducts QS, regulatory,
compliance assessments/audits and FDA Mock Inspections for State
of Readiness.
 Reviewing the most significant changes affecting medical device
standards and guidance documents
 Understanding the MDSAP (goals and strategy)
 Analyzing the MDSAP main differences with standard auditing
 Understanding grading of MDSAP non-conformances
 Assessing MDSAP Audit structure and reporting to regulators
 More than six Notified Bodies are in the Pilot Program, Office audits
and witnessed audits are required (conducted by regulators)
$6,475.00
Price: $3,885.00 You Save: $2,590.0 (40%)*
Register for 5 attendees
Global Regulatory Affairs & Compliance Consultant

2. 2-day In-person Seminar:
Implementing MDSAP (Medical Device Single Audit Program)
for Compliance Success
Global
CompliancePanel
Agenda:
Day One Day Two
Lecture 1: MDSAP
 Introductions and Background
 Guidance on the MDSAP program and pilot
 Is the Medical Device Single Audit Program (MDSAP)
mandatory?
 Concepts, principles and interpretation of the MDSAP
program
 Overview of the significant requirements
 Impact of the audit model on your organization and
audits
 MDSAP Guidance Documents
 Full details of the MDSAP pilot prior to 2017
 Pilot started in January 2014 (for 3 years, to Dec 2016)
 Certification Bodies from participating member states
can apply to become AO's
 Policies, Procedures, Templates and Forms (Policies,
procedures and other related documents supporting
MDSAP)
 Audit Procedures and Forms (Procedures and forms
supporting Auditing Organization Audits)
 Assessment Procedures and Forms (Procedures and
forms supporting Regulatory Authority assessments)
 Training Material (Auditing Organization and Regulatory
Authority training material)
 IMDRF/MDSAP WG and GHTF Documents (IMDRF
MDSAP WG and GHTF documents supporting the
program)
 What Auditing Organizations can apply to the MDSAP
Pilot?
 MDSAP findings system, including 5-point scoring
 FDA's "MDSAP Mid-Pilot Report
 MDSAP Companion Document and other Resources
Lecture 2: Recap of Day 2
 Interactive Discussions
 Review of MDSAP Auditing Documents and Case Study
Lecture 2: Exercise and Recap of Day 1
 Interactive Discussions
 Review of MDSAP Auditing Documents and Case Study
Lecture 1: MDSAP
 Recap from Day 1
 Background of MDSAP Program
 MDSAP Processes and Audit Sequence
 How can medical device manufacturers participate? How
to Participate in the Program?
 Audit Duration/Structure
 Grading of Non-Conformances and Nonconformity
Grading - Based on GHTF document SG3/N19
 Report Writing, Certification and submission to
Regulators
 Implications
 Potential Witness Audits by Regulators
 Primary differences between your current audit and an
audit conducted under MDSAP
 MDSAP Audit Process Timelines and Audit Time
Calculation
 Regulatory Authorities Oversight of the Auditing
Organizations
 Medical device manufacturers' quality management
system can be audited once for potentially five different
medical device markets
 Operational Requirements for Manufacturers and AO
After the Audit
 If MDSAP becomes mandatory for one or more
participating countries will manufacturers be expected to
be compliant with regulations in a jurisdiction that it does
not market?
 What is the link between the MDSAP Audit Criteria and
ISO 13485?
 Regulator's Acceptance of MDSAP Reports
 Training and Qualifications of MDSAP Auditors
 Will the European Union Ever Participate in MDSAP?
 On December 4, 2015, Health Canada announced its
decision to end the current Canadian Medical Devices
Conformity Assessment System (CMDCAS) program.
 From January 2019, Health Canada will only accept
MDSAP certificates, which will replace the current
CMDCAS requirement.
Lecture 3: Debrief/Adjourn
 Recap of topics and key discussion points and take
away message
 FAQs and latest MDSAP auditing trends

3. www.globalcompliancepanel.com
Kindly get in touch with us for any help or
information.
Look forward to meeting you at the seminar
GlobalCompliancePanel
What You will get
Special price on future seminars by
GlobalCompliancePanel.
Networking with industry's top notch professionals
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1 Learning Objectives
2 Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
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Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
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Fremont, CA 94539, USA
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Email: support@globalcompliancepanel.com
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Global
CompliancePanel
2-day In-person Seminar:
Implementing MDSAP (Medical Device Single Audit Program)
for Compliance Success