Preparing for FDA Medical Device Inspections – The Requirements
About This Course
Recognizing what to expect during an FDA inspection enables a medical device manufacturer to effectively prepare for the inspection. This instructor-led two-day course is designed to prepare domestic and foreign medical device manufacturers doing business or intending to do business in the United States to recognize and prepare for FDA pre- and post-market inspections.
This course focuses on identifying FDA inspection criteria, resources (including key standard operating procedures such as CP 7382.845) and practices used to plan, conduct, and assess inspections of medical device manufacturers.
Key Learning Objectives
On completion of this FDA medical device inspections course, you will be able to:
- Identify key requirements of the FDA’s Quality System (21 CFR Part 820) and Medical Device Reporting (21 CFR Part 803) Regulations
- Recognize the intent of regulatory requirements as described in preamble discussions
- Recognize key similarities and differences between 21 CFR Part 820 and ISO 13485:2016
- Identify inspectional resources used by FDA investigators
- Identify key elements/focus of FDA’s Quality System Inspection Technique (QSIT)
Who Should Attend
This course benefits quality professionals responsible for managing, facilitating, and participating in FDA inspections, as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.
This course is important for medical device professionals, especially those who conduct or participate in any project and/or quality management system activity.
Tutors
Course tutors selected from the following:
Nanci Dexter - Nanci has over 35 years of experience in the medical device and IVD industries. Nanci has created numerous quality systems for small and medium-sized companies, conducted mock FDA and ISO13485 audits and authored many worldwide regulatory submissions. Her diverse experience ranges from auditing, leading compliance remediation projects, conducting regulatory strategies and holding regulatory and quality management positions in both the United States and Europe.
Gert Sorensen - Gert Sorensen has worked in the field of Medical Device quality for the past 22 years in different roles; as a QA specialist within global companies producing class I, II and III Devices also including electronics and software. Gert has also worked as a consultant specialized in FDA 21 CFR compliance, Process Validation and Software Validation and as Notified Body Auditor. Gert has conducted internal audits, supplier audits and third-party audits under ISO 9001 and 13485, MDD 93/42/EEC, MDR 2017/745 and MDSAP. He has also conducted due diligence evaluations as well as capability assessments. He has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing global quality management systems; and developing and presenting quality-related training and seminars.
Related Courses
Preparing for FDA Medical Device Inspections – Practical Guidance
ISO 13485:2016 Overview and Country-Specific Medical Devices Regulations: Six-Course Bundle
Design Controls for Medical Devices and IVDs
Additional Recommended Courses
Writing Effective Nonconformity Statements During Medical Device QMS Audits
This virtual instructor-led one-day course will introduce you to the importance of writing effective nonconformity statements during medical device manufacturer quality management systems audits.
This course covers the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements; and how to recognize when to communicate nonconformities during an audit; and identify tools and tips for writing effective nonconformity statements.
In addition, learners will apply the concepts covered during the course through practical application. Working in groups, learners will review multiple nonconformity scenarios, develop nonconformity statements relative to the scenarios and participate in instructor-led analysis of the nonconformity statements.
This course pairs well with CQI IRCA-certified QMS Lead Auditor based on ISO 13485 2016 and MDSAP Requirements, EU MDR Internal Auditor (2 day), EU IVDR Internal Auditor (2 day), and MDSAP Internal Auditor Training (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 useful techniques to apply when writing effective nonconformity statements
- Review fundamental terminology important to writing effective nonconformity statements including audit, objective evidence, audit criteria, and nonconformity
- Evaluate the use of the acronym FOCAL as a tool for developing an effective nonconformity statement.
- Apply the three key principles when writing a nonconformity statement
Price: $800.00
ISO 13485:2016 Fundamentals of Medical Devices QMS Requirements for Regulatory Purposes
This virtual instructor-led two-day course covers the requirements of ISO 13485:2016, including the intent, meaning, and interrelationship of the ISO 13485:2016 clauses. This course will also introduce learners to ISO 13485:2016 Medical Devices – A Practical Guide. This guide was developed by ISO TC 210 (the developers of ISO 13485:2016) to assist medical device manufacturers in the practical application of the requirements of ISO 13485:2016 within a quality management system. Learners will demonstrate comprehension through individual and group activities throughout the course as well as a final course challenge.
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 key documents to help you understand ISO 13485:2016
- Recognize the primary elements of ISO 13485:2016
- Identify terms and definitions relative to the application of ISO 13485:2016
- Recognize similarities and differences between ISO 13485:2016 and the Quality System Regulation
- Demonstrate practical application of ISO 13485:2016 requirements through inspection scenarios
Price: $1200.00
ISO 14971:2019 Risk Management for Medical Devices and IVDs-Practical Application
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