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Course "Implementing MDSAP (Medical Device Single Audit Program) for Compliance Success" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
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)
And Much More...
Why should you attend:
Clear Understanding of MDSAP objectives, approach and the overall process
Develop, manage, and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions
To promote greater alignment of regulatory approaches and technical requirements
To promote consistency, predictability, and transparency of regulatory programs
What is MDSAP?
How MDSAP Works?
How does MDSAP fit with other certifications?
MDSAP Status
Beneficial to manufacturers of medical devices who are interested in marketing and selling devices in those countries (Regulatory Authorities)
Next Steps in 2017 and going forward?
Areas Covered in the Session:
International partners that are participating in the MDSAP Pilot include US FDA, Therapeutic Goods Administration of Australia, Brazil's Agencies’ Nacional de Vigilancia Sanitaria, Health Canada, Japan's Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program and the European Union (EU) are Official Observers
MDSAP Guidance Documents
Regulatory Authorities (RA's)
Auditing Organizations (AO's)
Audit criteria of the MDSAP program will include the requirements of ISO 13485 and the applicable requirements of the participating regulatory authorities
MDSAP Processes and Audit Sequence
Who will benefit:
This seminar will provide an overview and in-depth snapshot and a refresh of the MDSAP certification program. Those interested in how to prepare for the MDSAP audit and how to enhance their MDSAP audit system as a valuable regulatory compliance tool will also benefit from this course. Employees or functional areas that will benefit include:
Clinical Research Associates
Clinical Project Managers
Regulatory Affairs Professionals
Clinical Investigators and Clinical Research
Regulatory Affairs Management
Regulatory Affairs Specialists
Regulatory Project Leads/SME's
QA Auditors
Supplier Auditors
GxP Auditors
Compliance Specialists
Clinical Affairs
Quality Manager
Quality Assurance
Production/Operations
Consultants
Agenda:
Day 1 Schedule
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: Exercise and Recap of Day 1
Interactive Discussions
Review of MDSAP Auditing Documents and Case Study
Day 2 Schedule
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 2: Recap of Day 2
Interactive Discussions
Review of MDSAP Auditing Documents and Case Study
Lecture 3: Debrief/Adjourn
Recap of topics and key discussion points and take away message
FAQs and latest MDSAP auditing trends
Speaker:
David R. Dills
Global Regulatory Affairs & Compliance Consultant
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.
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