Inspection & Enforcement
Computerized Systems Inspections in the Medical Device Industry
This course has been designed by ISPE and EduNeering, Inc. in cooperation with the FDA/ORA, to assist FDA inspectors in recognizing the critical aspects of computerized systems in the medical device industry. The course explains how computerized systems are used in the medical device manufacturing process and provides an approach to inspecting these systems. This course does not cover the detailed review of software that forms part of a medical device; it covers only inspection of systems that automate part of the device production process or part of the quality system.
- Requirements for Computerized Systems Validation and Compliance
- Approach to Computerized Systems Validation and Compliance
- How computerized systems are used in the medical device industry
- How an investigator should approach computerized systems
- The focus of the investigator’s review
This course will introduce you to your role if you are called as an FDA witness. The course will help you distinguish among grand jury, deposition, declaration, and courtroom testimony. The course also discusses how to: prepare for testimony; identify the fundamental characteristics of appropriate courtroom conduct; and identify the components of effective testimony.
- Types of testimony
- On the stand
- After testifying
Destruction and Reconditioning
It is imperative that violative articles be removed from the market place to protect consumers from harm and, in the case of some labeling violations, from fraud or economic loss. FDA personnel are called upon to witness the destruction or reconditioning of violative products. The destruction and reconditioning of products are provided for in Sections 304 and 801(b) of the Food, Drug, and Cosmetic Act (FD&C Act).
Evidence and Proof
FDA takes action based on information collected and developed by investigational and analytical personnel. FDA’s ability to perform its function is based on the quality and care used in collecting and preserving information. Information is evidence; obtaining it properly is a vital portion of FDA’s law enforcement work. This course explores the different types of evidence and how to collect and preserve this evidence. You will learn the importance of clearly documenting all processes involved in collecting and testing evidence. The learner will become familiar with the different types of proof required in FDA cases. After completing this course, you should be able to recognize the processes involved in gathering evidence and proof, and the circumstances under which both can be used.
- Physical evidence
- Photographic evidence
- Written or printed evidence
- Types of testimony
- Elements of proof
- Actions within FDA’s jurisdiction
FDA 483s: Inspectional Observations
This course is designed to familiarize FDA staff with the history of the FDA 483, Inspectional Observations form, when it is issued to the inspected firm’s management, and how an FDA 483 can be annotated. After completing this course you will recognize the purpose of issuing an FDA 483. You will identify the kinds of inspectional observations that are included on an FDA 483, when it is issued to the inspected firm, and how to annotate it during the discussion with management.
- Purpose of an FDA 483
- Objectionable condition
- Reportable Conditions
FDA Establishment Inspection (EI)
FDA’s findings during establishment inspections prevent violative and potentially dangerous products from reaching the consumer. It is for this reason that all FDA inspectors, investigators, and analysts understand the fundamentals of performing an FDA establishment inspection. This course identifies FDA’s statutory authority in conducting establishment inspections. After completing this course, you will recognize the basics of FDA establishment inspections including the procedures for preparing, initiating, conducting, and concluding an inspection.
- FDA establishment inspections
- Conducting establishment inspections
- Preparing for an establishment inspection
- Procedures for initiating an inspection
- Handling inspection refusals
- Observations during an inspection
- Procedures for gathering evidence
- Interviewing facility personnel
- Procedures for concluding the inspection
FDA Establishment Inspection Report Writing
This course will familiarize FDA staff members who will conduct establishment inspections with the purpose of the establishment inspection report (EIR), what should be included in the report, and how to make the report readable. The course will also provide an introduction into the new “Turbo EIR” concept as a work in progress. After completing this course you should understand why FDA prepares reports using a standard format, what that format is, and how to make your reports readable. You will also be able to identify additional formats and alterations for the EIR.
- Additional Formats
FDA Good Guidance Practices (GGPs)
This course on FDA Good Guidance Practices (GGPs) explains which agency documents are considered guidance documents. It also explains why we have GGPs, their legal effect, how they are developed, and GGP implementation. This training fulfills a statutory requirement for the agency. After completing this course, you will be able to describe the history, development, issuance, and use of agency guidance, and you’ll learn how and why GGPs were established.
- Guidance documents
- GGPs origins
- Implementing GGPs
- Issuing guidance documents
- How guidance documents differ from regulations
Failure Investigations for Medical Device Manufacturers
This course will explore what a failure is, the regulatory and practical aspects of investigations, and the elements that make these investigations effective. It will also provide guidance on conducting a comprehensive investigation and on developing corrective actions that prevent future recurrences. Product or process failures are often unavoidable events encountered in medical device manufacturing. How you handle these failures, however, can be significant in your ability to maintain a state of control in operations and prevent future failures. The success of a failure investigation can often be tied to whether the investigation was comprehensive enough to actually identify the root cause of the event.
After completing this course, you will be able to recognize the basic definition of failures. You will be able to identify when a failure investigation should occur and the documentation required. You will also be able to describe the basic elements of a comprehensive failure investigation and the steps for management review and follow-up.
- Medical device product failure and GMP requirements
- Failure investigations
- Identifying the root cause of a failure
- Corrective and preventive actions (CAPA)
- Follow up the CAPA
- Documenting and communicating failures, investigations, and CAPA
Field examinations help to ensure the safety, purity, and effectiveness of products that are released for public use. Field exams cover the entire spectrum of FDA-regulated products, including foods, animal and human drugs and devices, biological products, electronic products for compliance with the Radiation Control Standards, and cosmetics for label standards. This course is designed to familiarize individuals with the “what, why, and when” of conducting examinations of products while performing inspections, sample collections, or surveillance activities. In this course you will learn the basics of field examinations. The course focuses on the purpose of field examinations and when they must be conducted. In addition, you will also learn about the types of field examinations, the equipment commonly used during field examinations, and how these examinations are conducted.
- A field examination
- When to conduct a field examination
- Types of equipment used when conducting a field examination
- Conducting a field exam
Handling an FDA Inspection
This course reviews the basics of handling an FDA inspection of a pharmaceutical and medical device manufacturing facility. The course will clarify the roles and responsibilities of personnel during an inspection with an emphasis on being prepared and maintaining a positive, professional relationship with FDA.
- Personnel Conduct
- Inspection Types
- The Process
- Samples and Photos
- End of Inspection
Import Operations 1: Background
This is the first in a series of three courses that addresses FDA import and export programs, procedures, and policies. Its purpose is to introduce the FDA import program and to familiarize the learner with the application of the law to products that are offered for entry into the US and intended for export from the US. This course includes information on key references, laws, and regulations related to imports. Learners should complete five courses in the Food and Drug Law series (FDA Jurisdictions, Criminal Acts Violations, Imports and Exports, Judicial Actions, and Prohibited Actions), as well as the courses Sample Collection, and Field Examinations, before taking this course.
- FDA approach to ensuring imported products meet US public health standards
- The FD&C Act and the treatment of foreign and domestic products
- Sections of the FD&C Act on imports and exports
- Sections of 21 CFR that address imports and exports of FDA-regulated products
- Sections of 19 CFR that address Customs enforcement of imports and exports
- Sections of 18 USC that address criminal activity associated with imports and exports
- Guidance and policy documents that provide more information about import and export operations
Import Operations 2: The Process
The second in the series, this course addresses pre-entry activities, types of entries, admissibility decisions, and resources that help FDA make sound admissibility decisions. The course also addresses the evaluation of entries, laboratory analysis, and what happens to products after examination. After completing this course, you will recognize how FDA regulates imported products and decides which products to admit. You will also recognize the process of import operations and how FDA enforces regulations if problems arise.
Learners should complete Import Operations 1: Background, as well as five courses in the Food and Drug Law series (FDA Jurisdictions, Criminal Acts Violations, Imports and Exports, Judicial Actions, and Prohibited Actions), Sample Collection, and Field Examinations, before taking this course.
- How FDA regulates imported products before entry into the US
- Types of entries for imported products
- How FDA makes entry decisions
- What resources are available to assist in determining admissibility
- Entries requiring further evaluation
- Entries requiring sample analysis
- Entries that have undergone further evaluation
- Enforcement tools available to FDA
Import Operations 3: Other Activities
This is the last in a three-course series that addresses FDA import and export programs, procedures, and policies. This course addresses how import filers participate in FDA's electronic review system, how FDA identifies and removes violative imports, and how domestic and import operations can help FDA identify potential problems. The course also addresses the responsibilities FDA shares with other government agencies, and the provisions that allow the export of products that do not comply with the FD&C Act.
Learners should complete five courses in the Food and Drug Law series (FDA Jurisdictions, Criminal Acts Violations, Imports and Exports, Judicial Actions, and Prohibited Actions), Sample Collection, Field Examinations, and the first two Import Operations courses before taking this course.
- How import filers participate in OASIS
- Who FDA shares information with to identify violative imported products in the US market
- How FDA regulates exports
- Export certificates
- Who FDA shares responsibility with
Interviews are an important part of virtually every operation performed by FDA inspectors, investigators, and analysts. Interviews are conducted during inspections, sample collections, recalls, and special investigations; therefore, it is important that FDA field personnel possess good interviewing skills and develop them as they move forward in their careers. After completing this course you will be able to recognize the fundamentals of conducting an effective interview. You will be able to identify the traits of a successful interviewer and the importance of appropriate interpersonal skills. You will also be able to identify appropriate questioning techniques to use in an interview.
- Purpose of an interview
- Preparing for an interview
- Specific considerations for the persons being interviewed
- Traits of a successful interviewer
- Keys to asking effective questions
- Nonverbal behaviors you should observe
Introduction to Quality System Regulations (QSR)
Employees play an active part in ensuring the quality of the product. This interactive program provides employees with an overview of FDA’s current Quality Systems Regulation for medical devices. Mastery of these concepts will provide employees with a good understanding of how the Quality System Regulation affects operations in manufacturing facilities. This program emphasizes the elements of a Quality System that help to ensure products are safe and effective and that manufacturing operations are compliant with current medical device Good Manufacturing Practices. This interactive program provides an overview of the major elements of a Quality System, including:
- Management responsibilities
- Design controls
- Document controls
- Process controls
- Purchasing controls
- Corrective and preventive actions
- Device labeling and packaging procedures
Part 11: Electronic Records; Electronic Signatures
The principle purpose of 21 CFR Part 11 is to ensure that when electronic records and signatures are used, they meet the minimum requirements of trustworthiness, reliability, and compatibility with FDA’s mission of public health and safety. This interactive lesson is designed to introduce you to the regulatory requirements for electronic records and electronic signatures, as well as FDA expectations for compliance. You will learn specific Part 11 requirements that govern the use of electronic records and signatures as well as FDA enforcement of Part 11.
- Part 11
- Basic requirements for electronic records
- Security requirements for electronic records
- Basic requirements for electronic signatures
- Controls for electronic signatures
- FDA enforcement of Part 11
Part 11: Electronic Records and Signatures — Application
This course will provide the learner with an understanding of how to implement Part 11 and what it means in terms of FDA’s enforcement policy for 21 CFR Part 11, Electronic Records; Electronic Signatures. The course discusses the Guidance for Industry; Part 11, Electronic Records; Electronic Signatures – Scope and Application, August 2003.
- Identify Steps to prepare for an inspection
- Electronic Signatures
- System Documentation
- Audit Trails
Photography for FDA Enforcement
This course covers the legal requirements of photographing evidence for FDA investigators who take photographs for law enforcement purposes. It addresses FDA’s authority to take pictures, and covers handling film and digital images, investigative techniques, the use of close-up photography, and the differences between 35 mm cameras and digital cameras.
- Digital Cameras
QSIT 1 - Beginning the Inspection
This is the first in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). This course provides guidance for inspecting medical device manufacturers against the Quality System Regulation, 21 CFR Part 820. After completing this course, you will be able to recognize the origin and scope of QSIT. You will also recognize the basic concepts associated with how to sample records for review during a QSIT inspection and report your findings (if necessary) in an Establishment Inspection Report (EIR).
- Other considerations
QSIT 2 - The Management Controls Subsystem
This is the second in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). The series provides guidance for inspecting medical device manufacturers against the Quality System Regulation, 21 CFR Part 820. This course will cover the Inspectional Objectives related to the Management Controls subsystem. Employees should complete QSIT 1: Beginning the Inspection prior to taking this course. They must also complete the Level I New Hire Investigator Certification. Employees should review the IOM (as it pertains to the inspection of medical device manufacturers), CP 7382.845 "Inspection of Medical Device Manufacturers," 21 CFR Part 820 - Quality System Regulation, and the Guide to Inspection of Quality Systems.
Topics include a discussion of each of the seven Management Controls Inspectional Objectives.
QSIT 3 - Design Controls Subsystem
This is the third in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). The series provides guidance for inspecting medical device manufacturers against the Quality System Regulation, 21 CFR Part 820. This course will cover the inspectional objectives related to the Design Controls subsystem. Before taking this course, you must complete Level I New Hire Investigator Certification and review the IOM (as it pertains to the inspection of medical device manufacturers), CP 7382.845 "Inspection of Medical Device Manufacturers," 21 CFR Part 820 - Quality System Regulation, and the Guide to Inspection of Quality Systems. You must have completed QSIT 1 - Beginning the Inspection and QSIT 2 - The Management Controls Subsystem.
- Beginning to inspect the Design Controls subsystem
- The design plan review
- The inputs and outputs of the design process
- Assessing acceptance criteria and design verification
- Design validation
- Completing the Design Controls subsystem inspection
QSIT 4 - The Corrective and Preventive Actions Subsystem
This is the fourth in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). The series provides guidance for inspecting medical device manufacturers against the Quality System Regulation, 21 CFR Part 820. This course will cover the inspectional objectives related to the Corrective & Preventive Actions subsystem. Before taking this course, you must complete Level I New Hire Investigator Certification and review the IOM (as it pertains to the inspection of medical device manufacturers), CP 7382.845 “Inspection of Medical Device Manufacturers,” 21 CFR Part 820 – Quality System Regulation, and the Guide to Inspection of Quality Systems. You must also have completed QSIT 1 — Beginning the Inspection, QSIT 2 — The Management Controls Subsystem, and QSIT 3 — The Design Controls Subsystem.
- Received data
- Failure investigations
- After actions
QSIT 5 — The Production and Process Controls Subsystem
This is the fifth in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). The series provides guidance for inspecting medical device manufacturers against the Quality System Regulation, 21 CFR Part 820. This course covers the inspectional objectives related to the Production and Process Controls subsystem. Before taking this course, you must complete Level I New Hire Investigator Certification and review the IOM (as it pertains to the inspection of medical device manufacturers), CP 7382.845 “Inspection of Medical Device Manufacturers,” 21 CFR Part 820 – Quality System Regulation, and the Guide to Inspection of Quality Systems. You must also have completed QSIT 1 — Beginning the Inspection, QSIT 2 — The Management Controls Subsystem, QSIT 3 — The Design Controls Subsystem, and QSIT 4 — The Corrective and Preventive Actions Subsystem.
- Selecting a process for review
- How selected process is controlled and monitored
- How to proceed if the process is/was not operating within specified limits
- How to confirm the validation of a process when the results cannot be fully verified
- Software and personnel
Quality System Inspection Technique (QSIT)
Manufacturing companies within the biomedical industry are subject to routine inspections of their quality systems by FDA. The FDA investigator(s) audits four major quality subsystems, which include: Management Controls, Design Controls, Corrective and Preventive Actions, and Production and Process Controls. QSIT is a "top-down" approach to evaluating a quality system. You will become familiar with the key objectives that an investigator will address when reviewing each subsystem. The subsystem approach focuses on the elements that are key to meeting the requirements of the quality system regulation.
- Assuring documents are in a state of compliance
- Inspectional Objectives for each subsystem:
- Management Controls
- Design Controls
- Corrective and Preventative Actions (CAPA)
- Production and Process Controls Subsystem (P & PC)
Recalls of FDA Regulated Products
Because recalls of FDA regulated consumer products have continued to increase on an annual basis, the monitoring of recalls of potentially hazardous consumer products is one of the most important activities performed by FDA personnel. This course helps you recognize FDA’s definition of a product recall and the contents of a recall letter, as well as the types, depth, and classification of a recall and the responsibilities of FDA personnel during a product recall.
- Product recalls
- Factors leading to product recalls
- Classifying product recalls
- Recall letter
- Responsibilities of FDA personnel during a recall
- Recall audit check
Risk Management 1: Key Concepts and Definitions
This course provides key concepts and definitions necessary to understand Risk Management. The course focuses on Risk Management as it applies to FDA and its regulated industries. This course is also designed to provide an understanding of Risk Management as defined by the International Organization for Standardization (ISO).You’ll be able to define risk and related terms. You will be able to identify the ways risk can be expressed, differentiate between safety and risk, and describe the criteria FDA uses to judge safety for different types of products. And you’ll learn the risk management process steps.
- Defining risk
- Calculating and expressing risk
- How FDA relates risk to safety
- Risk management
Risk Management 2: Pharmaceutical cGMPs for the 21st Century
FDA launched “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach” in order to stay current with advances in pharmaceutical manufacturing and to effectively allocate its limited regulatory resources. This course is a follow up to Risk Management 1 and focuses on the importance of the FDA initiative Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach. This course will familiarize learners with the purpose and provisions of the initiative, why it was undertaken, its scope and goals, and the progress that has been achieved.
- Purpose of the initiative
- Principles that guide the initiative
- Action steps FDA has planned
- Milestones that have already been achieved
- Additional accomplishments
- Risk-based quality systems
- Future of the initiative
Samples are the starting point for nearly all actions taken by FDA. Samples may prove a violation, interstate commerce, jurisdiction, and responsibility, the four elements of proof required for most FDA actions. This course explores sample collection as a critical responsibility of field personnel. It explains the purpose of sampling and covers how to properly perform sampling. You’ll recognize the reasons for collecting and maintaining samples, and identify the major samples types, as well as the differences between domestic and import samples. You will recognize how to prepare and conduct proper sampling. Finally, you will be able to identify the appropriate steps for submitting a sample.
- Reasons for collecting samples
- Sample types
- Preparing for sample collection
- Determining sample size
- Sampling techniques
- Conducting sampling
- Sample submission
- Maintaining sample validity
This course provides an overview of the broad spectrum of investigations performed by FDA. These investigations include consumer complaints, disaster investigations, surveillance, health fraud, tampering, and criminal investigations.
After completing this course, you will be able to identify the purpose of special investigations. You will also learn the properties of special investigations, as well as what to look for during each of these investigations.
- Complaint investigations
- Surveillance investigations
- Disaster investigations
- Health fraud investigations
- Product tampering investigations
- Criminal investigations