Medical and Device 2017 - Medical Device Single Audit Program for Compliance Success 2017

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 Agencia 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 who 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. He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency-EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company's commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing. He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills' academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ's Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.
Location: Boston, MA Date: May 4th & 5th, 2017and Time: 9:00 AM to 6:00 PM
Venue: Embassy Suites Boston Logan Airport
Address: Embassy Suites Boston Logan Airport 207 Porter St, Boston, MA 02128, USA
Price:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until March 31, Early Bird Price: $1,295.00 From April 01 to May 02, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
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