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Course "How FDA Trains Its Investigators to Review Sub-Systems for State of Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Think like and behave like an FDA investigator and recognize your greatest risks and vulnerabilities. Your authority to enter and inspect establishments is predicated upon specific obligations to the firm per FDA's documentation and we will review in detail. It is FDA's responsibility to conduct all inspections at reasonable times and within reasonable limits and in a reasonable manner. FDA needs to proceed with diplomacy, tact and persuasiveness. During inspections or investigations, when FDA has evidence of conditions whereby there is a reasonable probability the associated products will cause imminent and serious adverse health consequences or death...we will address this during the seminar and what happens next. By directing your attention to the major areas in a firm's quality system, you should be better able to determine if the firm's quality system is in control. Using the subsystem approach, you may find less opportunity to cite minor deviations from the quality system regulation than in the past. However, you will be citing more serious (systemic) deviations from the regulation. FDA inspections are typically the starting point for the sequence of enforcement actions, since serious violations discovered at inspections will often result in Warning Letters, which in turn, if not properly responded to, can turn into seizures, injunctions, prosecutions, or recalls or consent decrees. So you can look at the number of inspections as one indicator of how aggressive FDA is being regarding enforcement. The seminar will provide an in-depth overview of the various enforcement actions, with primary focus an emphasis on Warning Letters, Seizures, Injunctions and Prosecutions. We will address FDA enforcement stats in this space with some regularity, trying to discern patterns and trends as related to current state vs. future state. We will address the critical approach necessary to develop a quality remediation plan for inspectional observations (e.g., FDA Form 483/Warning Letter) submitted by FDA. We will examine the importance of having a detailed understanding of the observations and their impact on all quality sub-systems. Management will need to ensure a clear and scientific strategy is developed and communicated to FDA. This is critical to re-establish credibility with FDA and, hopefully, prevent an escalation to a Warning Letter or injunction (i.e., Consent Decree). There are also important technical writing and formatting rules that should be followed when writing one's response. Inadvisable response strategies and deficient remediation efforts will be discussed. Ultimately, the hard work in developing a quality remediation plan will help ensure FDA does not proceed to enforcement actions such as a Warning Letter or worse. The Seminar will provide all details relevant to Pre and Post-Inspectional activities, tactics, strategies and is a must for those who have never gone through an FDA inspection and as a "refresh" for those who have to ensure your "state-of-readiness" and being prepared. Why should you attend? • What starts the FDA inspection and by what Authority? • Authority to Enter and Inspect • Inspectional Guidelines and Approaches • Foreign Inspection • Reports and Observations: What Next? • Secret of using Inspectional Tactics and Techniques • Evidence Development • Inspection Warrants and Interviewing Methods • Address different types of Warning Letters and enforcement actions • Understanding FDA's enforcement strategy and what it means to your firm • Understanding how auditors think and their expectations • Being prepared to receive regulatory inspections • Recognizing when inspectional findings or events indicate potential regulatory actions • When to take or not immediate action during an inspection • Making better responses to FDA both during and following inspections • How to make written procedures and training more effective • How to increase the effectiveness and efficiency of internal audits • How to identify effective compliance metrics • Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion as applicable • Review and discuss pain points, challenges and solutions • Understand the use of FDA’s Administrative Enforcement Tools • Inspectional Options based on Inspectional Violations • Current FDA Enforcement Priorities: • Address Civil and Criminal Penalties • Collateral Damage • Keys to Compliance Programs • Why Does FDA Enforce • FDA’s New Enforcement Culture • FDA’s Expectation on Replying to Inspections and Warning Letters • How to Handle the Inspection • Lessons Learned from the Actual Response • How to Avoid Adverse Inspections and Warning Letters - its simple - COMPLY! • Learn the methodology and strategy behind Warning Letters, Seizures, Injunctions/Consent Decrees) and Criminal Prosecution • Understand what the OIG does as an enforcement body with FDA and the latest trend with CIA (Corporate Integrity Agreements) • Why Recalls are an example of an Enforcement Tool • Identify and discuss the latest FDA and industry trends with statistics and data regarding enforcement and inspection data - FDA’s Inspections Database • Understand how Surveillance Inspections are conducted on a routine basis to satisfy FDA’s responsibilities to inspect manufacturing facilities. • Understand how Compliance Inspections are conducted in response to violative surveillance inspections and when a need arises to inspect a facility for-cause. • Leave the seminar with a better understanding of FDA’s new approach to inspections and why state of readiness and preparation are business critical going forward Areas Covered in the Session: FDA History, Inspectional Strategy and Techniques • SOPs • Training • Audits • Managing the Inspection and State of Readiness • Responding to FDA Inspectional Observations (483s)/Warning Letters • Mock Inspections • Compliance Program 7356.002, Drug Manufacturing Inspections and other Compliance Programs Device Manufacturing Inspections • IOM (Investigations Operations Manual) • RPM (Regulatory Procedures Manual) • Field Management Directives • Inspection Technical Guides and official documents used as reference material for investigators and other FDA personnel Warning Letter and Notice of Violation Responses/Communicating with FDA • Strategy and Remediation Implementation • Drafting • Liaison with FDA to ensure Close-out • Effective Responses State of Readiness/Practice/Mock Inspections • Prepare for "real" inspections by being ready and not caught off guard • Practice Sessions and Dress Rehearsals on Day Two Speaker: David R. Dills Regulatory Affairs & Compliance Consultant, David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus. Agenda
Day 1 Schedule: FDA History, Inspection Preparation, Handling and Closure • How a firm should prepare for an FDA inspection • Ways to train employees in view of the inspection • Field Management Directives • How to ensure that required documentation is in place • How to interact with the investigator-DO’s and DON’T’s • What companies should do when the inspection ends • How to reply to 483’s and warning letters • Legal implications of non-compliance • Post inspection actions • Why inspections are conducted and by what statutory authority • The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents • What is subject to FDA purview and what's off-limits • Understand and apply the do's and don'ts and comprehend that preparation is the key to success • What are the prohibited "Acts" and the enforcement categories that you need to deal with • What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key • The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel • How to respond to findings and facilitating the documentation and remediation process...and reaching final closure • Define clear responsibilities, roles and goals for personnel involved in SOP development • Management Controls and Inspectional Objectives: Determine whether management with executive responsibility ensures that an adequate and effective quality system has been established (defined, documented and implemented) at the firm. Because of this, each inspection should begin and end with an evaluation • Design Controls and Inspectional Objectives: Control the design process to assure that devices meet user needs, intended uses, and specified requirements. Attention to design and development planning, identifying design inputs, developing design outputs, verifying that design outputs meet design inputs, validating the design, controlling design changes, reviewing design results, transferring the design to production, and compiling a design history file help assure that resulting designs will meet user needs, intended uses and requirements. • CAPA Inspectional Objectives: Purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. • Medical Device Reporting (MDR) Regulation, Medical Device Tracking and Corrections and Removals are also linked to the CAPA Sub-System. • Know exactly what establish means in the eyes of FDA as "define, document (in writing or electronically), and implement" • Classroom exercise-Mock FDA Inspection/Role Playing ________________________________________ Enforcement Actions • The Warning Letter generally states that the firm has made products that are adulterated, violating the Food, Drug, and Cosmetic Act and that the firm has a very limited amount of time to address the problem(s) before the FDA takes further regulatory action against the firm, the adulterated product, and responsible individuals • Established background of prior warning • Responding to a WL/483 and group discussion with written responses to FDA • Types of Warning Letters on the FDA Website • Review of recent WL’s and trends • Group discussion with Response Letters • Seizures and General Guidelines • Injunctions/Consent Decrees • Corporate Integrity Agreements • Criminal Prosecution/Fines - In some cases, usually involving fraud, FDA and federal prosecutors will file criminal charges against an individual; if found guilty, the person is subject to fines and prison time. • Injunction is a civil judicial process initiated to stop or prevent violation of the law, such as to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur. Day 2 Schedule: • Production and Process Controls Inspectional Objectives: Purpose is to manufacture products that meet specifications. Developing processes that are adequate to produce devices that meet specifications, validating (or fully verifying the results of) those processes, and monitoring and controlling the processes are all steps that help assure the result will be devices that meet specifications. • Sterilization is also linked to P&PC’s and the primary device specification is the desired Sterility Assurance Level (SAL). Other specifications may include sterilant residues and endotoxin levels. • FDA’s use of Sampling Plan Instructions & Tables when reviewing your compliance auditable files and records. • Compliance Program Guidance Manual for Inspection of Medical Device Manufacturers (CP 7382.845). • Investigations Operations Manual (IOM). • Code of Federal Regulations, Title 21 (21 CFR) Part 820 Quality System Regulation • Compliance Policy Guides (CPG) for devices (Sub Chapter 300). • FDA’s Inspection Guides for Pharmaceuticals and Medical Devices • Domestic and Foreign Inspections • Pharma: Quality System assures overall compliance with CGMPs and internal procedures and specifications. • Pharma: Facilities and Equipment System includes activities which provide an appropriate physical environment and resources used in the production of APIs. • Pharma: Materials System includes measures and activities to control starting materials, intermediates, and containers. It includes validation of computerized and inventory control processes, storage, and distribution controls. • Pharma: Production System includes measures and activities to control the manufacture of APIs, including in-process sampling and testing, and process validation. • Laboratory Controls and Operations and what to expect from FDA • Pharma: Packaging and Labeling System includes measures and activities that control the packaging and labeling of intermediates and APIs. Exercise and Recap of Day 2 • Exercise • Quiz Audience
• Managers responsible for GMP/GLP/GCP compliance and seeking a better understanding of FDA, inspections, regulatory actions and how they can improve their own firm's operations and monitoring of their state of GMP compliance • Individuals who come in contact with regulatory inspectors • Auditors • Compliance/Regulatory affairs Professionals • QA/QC Professionals • Senior Management Executives (CEO, COO, CFO, etc.) • Manufacturing Managers, Supervisors & Personnel • Project Managers • Regulatory Affairs Management • Regulatory Affairs Specialist • Auditors • Compliance Officer • Compliance Specialist • Clinical Affairs • Quality Assurance Management • Marketing & Sales • Distributors/Authorized Representatives • Legal Counsel • Engineering/Technical Services • Operations/Manufacturing • Consultants