Addressing Key FDA Citations with Training Align UL EduNeering Courses to Top FDA Warning Letter Topics
Addressing Key FDA Citations with Training Align UL EduNeering Courses to Top FDA Warning Letter Topics This paper recommends specific UL EduNeering online courses from our FDA Inspection and Enforcement Library, as well as our GMP Medical Device Library, that cover the most cited Warning Letter topics from FDA inspectors to Medical Device companies. Many of the courses noted here are authored by the FDA, as well as EduQuest, a leading Life Science regulatory consulting firm, and David C. Peterson, UL s subject matter expert in the interrelated fields of organizational development, Good Manufacturing Practices (GMPs) and curriculum development. Identifying the GMP/QSR Deficiency Topics This paper is based on an analysis of the FDA Warning Letter topics sent to Medical Device companies (in cgmp/qsr/manufacture subject) from August to December 2010. In all, 112 deficiencies were identified where inspectors noted that the methods used in, or the facilities or controls used for, their manufacture, packing, storage or installation are not in conformity with the current Good Manufacturing Practice (cgmp) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. UL provides courses that focus on these topics so quality and auditing teams can understand the expectations of the FDA. Here are the 8 most cited subjects (ranked from highest to lowest, listed with the percentage of instances) and our suggested courses. Page 2
1. Corrective and Preventive Action (15%) Failure to establish and maintain procedures for implementing corrective and preventive action as required by 21 CFR 820.100(a). Key Topics QSIT 4 The Corrective and Preventive Actions Subsystem (FDA53): This course is one in a series of four written by the FDA for inspectors 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 Corrective and Preventive Actions subsystem. QS Regulation 7: Corrective and Preventive Action (QSR07): The seventh in a series of Quality System (QS) Regulations, this course focuses on Corrective and Preventive Action (21 CFR Part 820 Subpart J). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. The intent of 21 CFR 820.100 is to correct or prevent poor practices, not simply to correct or prevent bad products. Correction and prevention of unacceptable quality system practices should result in fewer nonconformities related to products. Learners will become familiar with a manufacturer s responsibilities relative to the corrective and preventive action requirements of the QS Regulation. 2. Complaint Management (6%) Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Identifying the GMP/QSR Deficiency Topics 1. Corrective and Preventive Action (15%) 2. Complaint Management (6%) 3. Document Control (6%) 4. Device History Record (5%) 5. Design Control (5%) 6. Design Validation Procedures (4.5%) 7. Training (3%) 8. Quality Audits (3%) FDA-Authored QSR Library Complaint Management for Medical Device Manufacturers (DEV46): This course reviews the importance of properly responding to reports of alleged medical device problems. The learner will be able to apply the knowledge acquired to handle complaint events in a manner that is compliant with FDA regulations. Learners will understand the FDA s definition of a complaint, effective complaint handling systems, including CAPA, and steps for investigating a complaint. Page 3
Special Investigations (FDA25): This course provides an overview of the broad spectrum of investigations performed by the FDA. These investigations include consumer complaints, disaster investigations, surveillance, health care fraud, tampering and criminal investigations. Learners 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. 3. Document Control (6%) Your firm failed to adequately document acceptance activities for finished devices as required by 21 CFR 820.80(e). QS Regulation 4 (QSR04): Document and Purchasing Controls: this course focuses on the Document Controls requirements of 21 CFR Part 820, Subpart D and the Purchasing Controls requirements of 21 CFR Part 820, Subpart E. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Design Control Regulations for Medical Device Manufacturers (DEV40): This course introduces FDA design control regulations and provides basic information about the key procedures followed during the design and development of a product. The design plan requires documentation of training, planning validation, design transfer and changes, formal review, a design history file and human factors. This course focuses on the importance of documentation. 4. Device History Record (5%) Failure to maintain adequate device history records (DHR), as required by 21 CFR 820.184. Our suggested course: QS Regulation 9: Records (QSR09): This course focuses on Records (21 CFR Part 820 Subpart M). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices.... Page 4
One of the basic themes of the Quality System Inspection Technique is the Establish Test. The QS Regulation requires many procedures to be established and defines establish as define, document (in writing or electronically), and implement. Records play a vital role in the FDA s ability to confirm that procedures have been appropriately implemented and, on a broader scope, that an adequate and effective quality system has been established and maintained by the firm being inspected. 5. Design Control (5%) Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30. Design Control Regulations for Medical Device Manufacturers (DEV40): This course introduces FDA design control regulations by providing basic information about the key procedures followed during the design and development of a product. The design plan requires documentation of training, planning validation, design transfer and changes, formal review, a design history file and human factors. Records play a vital role in the FDA s ability to confirm that procedures have been appropriately implemented. QS Regulation 3: Design Controls (QSR03): This course explains the purpose of design control requirements. The learner will be able to identify the scope of the regulation and recognize requirements for design control procedures, planning, input and output, review, verification, validation, transfer, changes and the design history file. Manufacturers establish a system to control their design process so devices meet user needs, intended uses and specified requirements. The FDA believes that unless manufacturers apply appropriate design controls during development, a finished device may not be safe or effective for its intended use. Therefore, to comply with and implement the requirements of 21 CFR 820.30, Design Controls, manufacturers must adopt current and effective methods and procedures for designing devices. Page 5
6. Design Validation Procedures (4.5%) Failure to establish and maintain adequate procedures for validating the device design in order to ensure that devices conform to defined user needs and intended uses, and perform risk analysis where appropriate, as required by 21 CFR 820.30(g). Our suggested course: QSIT 3 Design Controls Subsystem (FDA52): This course 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 Design Controls subsystem. Topics include: 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, and Completing the Design Controls subsystem inspection. 7. Training (3%) Failure to establish adequate procedures for identifying training needs for ensuring that all personnel are trained to adequately perform their assigned responsibilities and for documenting training, as required by 21 CFR 820.25(b). Our suggested course: FDA Training and Qualification Requirements (PHA67): This course focuses on an effective personnel training and qualification process, which can produce a competent workforce, leading to a reduction of errors/deviations, customer complaints, regulatory risk and operational costs. This course will identify FDA requirements concerning training and qualification, responsibilities of personnel, records that need to be maintained and how to measure training and qualification. 8. Quality Audits (3%) Failure to establish written procedures for a third party to conduct quality audits (21 CFR 820.22). A third party is performing quality testing on the protective lens, but no procedures have been established for the third party firm. Principles of Auditing (PHDV69): This course focuses on the purpose and conduct of internal and external quality audits. It discusses the purpose of conducting audits, and focuses on the benefits to be derived if audits are conducted properly. It begins with a discussion on establishing an audit program to achieve internal GMP compliance. The course focuses on the actual preparation, conduct and follow-up associated with an internal audit. Page 6
Finally, the importance of establishing corrective action and follow-up and how these aspects of the audit program can yield opportunities and quality improvements will be illustrated. Learners will be able to discuss the importance of an effective audit program, the benefits that can result, actual conduct of an audit and how proper corrective action and follow-up yield the ultimate benefits of the program. Vendor Certification for Pharmaceutical Manufacturers (PHDV85): This course discusses the process of vendor certification a means of ensuring that a company is receiving the best possible materials, products and services from its vendors or suppliers. This course covers the common practices and concepts associated with vendor certification includeing vendor audits and testing. FDA-Authored QSR Library The FDA-authored QSR courses, included in both the GMP and FDA Inspection and Enforcement Libraries, reflect the FDA s most current requirements, priorities and policies in the areas of quality systems, import operations, medical device regulations, drug safety and more. The QS Regulation requires that each manufacturer shall establish and maintain a quality system that is appropriate for the specific device(s) designed or manufactured, and that meets the requirements of this part. If manufacturers do not implement certain GMP requirements which are qualified by the term where appropriate, they should document their justification for nonimplementation. The 11 QSR courses specify general objectives such as use of trained employees, design reviews, design validation, calibrated equipment, process controls, etc., rather than methods, because a specific method would not be appropriate to all operations. This course will identify FDA requirements concerning training and qualification, responsibilities of personnel, records that need to be maintained, and how to measure training and qualification. Page 7
About UL EduNeering UL EduNeering is a business line within UL Life & Health s Business Unit. UL is a global independent safety science company offering expertise across five key strategic businesses: Life & Health, Product Safety, Environment, Verification Services and Enterprise Services. UL EduNeering develops technology-driven solutions to help organizations mitigate risks, improve business performance and establish qualification and training programs through a proprietary, cloud-based platform, ComplianceWire. For more than 30 years, UL has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors. Our global quality and compliance management approach integrates ComplianceWire, training content and advisory services, enabling clients to align learning strategies with their quality and compliance objectives. Since 1999, under a unique partnership with the FDA s Office of Regulatory Affairs (ORA), UL has provided the online training, documentation tracking and 21 CFR Part 11-validated platform for ORA-U, the FDA s virtual university. Additionally, UL maintains exclusive partnerships with leading regulatory and industry trade organizations, including AdvaMed, the Drug Information Association, the Personal Care Products Council and the Duke Clinical Research Institute. 202 Carnegie Center Suite 301 Princeton, NJ 08540 609.627.5300 UL and the UL logo are trademarks of UL LLC 2013. uleduneering.com WP/11/120913/MD