Combination Products GMP and Regulatory Overview

ISO 14971:2019 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks associated with the identified hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s quality management system.

This virtual instructor-led two-day course presents the key foundations of the risk management process defined in ISO 14971:2019 and provides expert tips on how to navigate the process including review of TIR 24971:2020.

This course is highly interactive and includes practical instruction, case study exercises and a competency assessment.

This course also includes a self-paced two-hour ISO 14971:2019 overview eLearning module that must be completed prior to the start of the live instruction.

This course pairs well as a prerequisite to Design Controls for Medical Devices and IVDs (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

• Identify regulatory requirements for risk management:
  • European Regulation EU 2017/745 (EU MDR)
  • European Regulation EU 2017/746 (EU IVDR)
  • 21 CFR 820.30(g)
• Identify requirements of key International Standards relative to risk management:
  • ISO 14971:2019
  • ISO 13485:2016
• Recognize risk management definitions and principles
• Identify how risk management affects quality management system practices
• Recognize one method for the practical application of risk management principles

Who Should Attend
This course is vital for any medical device professional looking to expand their knowledge on comprehensive risk management processes and explain their interactions with the entire lifecycle of a medical device from conception to decommissioning and disposal.

Price: $1200.00

This virtual instructor-led course was designed and developed by the Medical Device Single Audit Program (MDSAP) Lead Project Manager responsible for the team that designed, implemented, and maintained the MDSAP program.

This training focuses internal auditors on the applicable MDSAP country-specific requirements that are applicable to the auditee organization. This focus, when used in conjunction with an existing ISO 13485 internal audit program, will provide the comprehensive coverage necessary to assure all applicable MDSAP regulatory requirements are audited. In addition, resources and insight into how MDSAP Auditing Organizations establish competence of their auditors will be discussed.

An “MDSAP Lite” audit tool will be provided including country-specific requirements and hyperlinks to the specific regulatory requirements (audit criteria) relative to each country-specific requirement. Through expertly designed individual and group tasks and activities, learners will demonstrate how to identify applicable country-specific requirements, how to plan the time necessary to conduct the audit of applicable country-specific requirements, how to plan an MDSAP Lite audit, as well as how to identity, document, and grade country-specific nonconformities.

This training is essential to anyone engaged in planning or conducting internal audits of an organization participating in MDSAP.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

• Describe an MDSAP Audit and identify criteria used during an MDSAP Audit
• Recognize International Medical Device Regulators Forum (IMDRF) governing procedures relative to MDSAP Auditing Organizations
• Recognize the competency and training requirements for AO auditors
• Recognize the structure and utility of the “MDSAP Lite” internal audit approach and “Toolkit”
• Calculate audit time and plan an MDSAP Lite internal audit
• Identify nonconformities, write nonconformity (NC) statements, and support the nonconformity statements with audit evidence
• Identify post-audit MDSAP activities including NC grading
• Recognize the outcomes and goals of an MDSAP audit

Price: $1200.00

This virtual instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU IVDR. This course also focuses on ISO 13485:2016 relative to its correspondence with the EU IVDR.

This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union In Vitro Diagnostic Regulation (EU IVDR).  The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning and conducting EU IVDR audits according to NSF’s formal, documented EU IVDR Audit Model.

This course includes a two-hour eLearning prerequisite module, EU IVDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key pre- and post-market requirements associated with EU IVDR – standard regulatory requirements that must be met by all In Vitro Diagnostic manufacturers wishing to do business in the EU regardless of IVD classification.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

• Identify Key Articles and Annexes of the EU IVDR
• Recognize Intent of Requirements as Described in Recitals
• Identify Classification Implementing and Classification Rules
• Identify General Safety and Performance Requirements (GSPRs)
• Recognize Content of Technical Documentation
• Identify Post-Market Surveillance Reporting and Vigilance Obligations
• Recognize one EU IVDR Audit Model
• Plan an EU IVDR Audit
• Document Nonconformities against EU IVDR requirements

Who should attend:

This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU IVDR, for managers of audit programs, and for anyone who will be the subject of or participate in an EU IVDR audit. Delegates should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.

Price: $1200.00