Seminar on What You Need to Do to Prepare for a Successful Inspection

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

Who Will Benefit:

This seminar will provide an overview and in-depth snapshot of the process for preparing for and managing an FDA inspection efficiently, effectively and successfully. You will learn and understand how FDA trains its investigators and inspectors so that you can prepare and always be in a state of readiness. Attendees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the FDA inspectional process, strategy, the tools to be used to assess and gauge state of preparation and readiness, including:

• 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

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