Best Practices for an Effective Quality Assurance Auditing for FDA Regulated Industries, ISO13485:2016 and MDSAP
Course Director: Jackelyn Rodriguez
Course Cost | Course Location | Course Date
June 24-25, 2019
Doubletree by Hilton Cariari San Jose-Costa Rica
San Antonio de Belén, Ciudad Cariari
Aditional Course List: Click here
Quality assurance auditing is a critical quality system requirement, by every medical device CGMP regulation published worldwide. Quality Assurance Auditing is a corner stone of FDA Regulations and ISO Standards-required Quality Systems, without which compliance to quality standards is not possible.
The aim of this 2-day course is to provide information and knowledge about the internal auditing of the standard ISO 13485:2016. This course is intended for the management and active teams, internal auditors and persons of interests in ISO 13485. This course will also provide understanding to first, second and third-party auditors learn the ISO 13485:2016 auditing process with an important linkage to MDSAP audit principles.
This intensive two-day course is intended for medical device quality professionals aiming to build on their knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in their organization. Attendees will learn the principles and practices of effective quality management systems process audits in accordance with the ISO 13485:2016 and ISO 19011:2018 as well as the new Medical Device Single Audit Program (MDSAP).
This course provides the rationale, strategies, techniques and tips, on how to plan and perform effective quality assurance audits that will comply with both ISO 1485:2016 and MDSAP. The course explores the politics, psychology and all the technical aspects of auditing, including discussions of their logistics, tools, and frequency. The course evaluates the talents and personnel characteristics required of a good auditor and those required of an excellent auditor.
The course will include:
- An overview of ISO 13485:2016 Auditing Principles
- An overview of MDSAP Auditing Principles
- An overview of ISO 19011:2018 Auditing Principles
- Auditor responsibilities and competence requirements
- Internal audit planning process and execution
- Documentation and reporting of non-conformities
- Internal audit report
- Internal audit corrective actions verification and closure
This course is designed so that you will:
Internal Audits are an essential tool to help organization to anticipate and prevent potential problems and weaknesses Implement proven best practices to minimize deficiencies Identify trends in findings and current ISO13485:2016 and MDSAP requirements.
Learn how to prepare for, perform, close-out and follow-up audits and how to get the best out of audits Tie audits to corrective and preventive action (CAPA) programs Be able to "sell" management on implementing effective internal audits and supplier/contractor audits
- · Understand quality management definitions, concepts, and guidelines
- · Understand the purpose of the ISO 9000 series
- · Understand the requirements of the ISO 13485:2016 standard
- · Understand the roles and responsibilities of the auditor
- · Apply ISO 19011:2018 concepts, new terminology and guidelines
- · Understand the types of risks and opportunities associated with auditing
- · Recognize the principles, practices, and types of audits
- · Conduct all phases of an audit adopting a risk-based approach, particularly in the section of audit planning
- · Prepare and present effective reports
- · Understand the role of objectives, scope and criteria in the audit process
- · How to plan audits
- · Conduct audit team selection
- · Initiate the audit and conducting opening meetings
- · Understand audit team leader responsibilities
- · Communicate effectively during the audit
- · Apply the latest auditor techniques and identify appropriate use
- · Conduct on-site activities
- · Prepare audit conclusions
- · Conduct closing meetings
- · Report audit results
Students receive comprehensive course manuals with reference materials.
Who Should Attend
This two-day course is designed for quality managers, auditors, regulatory/compliance professionals, production managers and top management interested in learning the value of a "good audit" to the company, how to prepare for a "good audit", and how to enhance QA Auditing as a valuable quality assurance and regulatory compliance tool.
- · Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
- · Individuals interested in conducting ISO 13485:2016 and MDSAP first-party or second-party audits
- · Management representatives
- · Internal auditors
- · Consultants
Questions & Wrap-Up When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization, department or employees functional responsibility.
All of course can be delivered on-site and can be fully customizable