This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
A key component of this webinar is the discussion of the tricks and techniques that inspectors use to elicit information. How you react and respond when they occur could impact your results.
Other key communications skills will be presented in the context of the inspection and interpersonal exchanges between inspectors and company associates being questioned.
We will complete the webinar by discussing how to handle, at the moment, adverse findings as they are identified by the inspector so as to not compound the issues and severity of the findings.
If you are in any regulated business - pharmaceuticals, or medical devices, you will experience an inspection by the U.S. Food and Drug Administration (FDA). According to the Food, Drug, and Cosmetic Act, "Registered domestic drug establishments shall be inspected by the FDA at least once every two years." Depending upon the inspection type and the circumstance, inspections may occur more frequently.
The outcome of those inspections can have a grave significant impact on your business even if you and your colleagues have done everything "right." How you and others behave and interact with FDA inspectors can have an impact on the results reported. Interacting with inspectors is not a natural behavior, effective techniques must be learned and mastered if those inspections are to have positive outcomes.
If you are in any regulated business - pharmaceuticals, or medical devices, you will experience an inspection by the U.S. Food and Drug Administration (FDA). According to the Food, Drug, and Cosmetic Act, "Registered domestic drug establishments shall be inspected by the FDA at least once every two years." Depending upon the inspection type and the circumstance, inspections may occur more frequently.
The outcome of those inspections can have a grave significant impact on your business even if you and your colleagues have done everything "right." How you and others behave and interact with FDA inspectors can have an impact on the results reported. Interacting with inspectors is not a natural behavior, effective techniques must be learned and mastered if those inspections are to have positive outcomes.
Charles H. Paul
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer, and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars on a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.
Surviving and Thriving Organizational Change and Loss: The …
Impact Assessment and Risk Management for Change Control
Excel Deep Dive: Advanced Tips & Techniques – A 3-hour Work…
How to Write Effective Audit Observations: The Principles f…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Marijuana: Compliance and Safety in the Workplace
FDA Regulation of Artificial Intelligence/ Machine Learning
Stressed Out: How to Handle Conflict, Difficult People and …
2025 Top Employment Regulations That Will Impact Employers!
How to Handle Workplace Conversations Around Politics and R…
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud,…
How to Give Corrective Feedback: The CARE Model - Eliminati…
Improving Employee Engagement & Retention Through Stay Inte…
SOPs - How to Write Them to Satisfy those Inspectors
Why EBITDA Doesn't Spell Cash Flow and What Does
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Marketing to Medicare or Medicaid Beneficiaries - What You …
Human Error Reduction Techniques for Floor Supervisors
Documenting Misconduct that Will Stand Up in Court
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Project Management for Non-Project Managers - How to commun…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Humane Layoffs: How to Let People Go with Compassion and De…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Sunshine Act Reporting - Clarification for Clinical Research
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Female to Female Hostility @Workplace: All you Need to Know
Onboarding is NOT Orientation - How to Improve the New Empl…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Managing Toxic & Other Employees Who Have Attitude Issues
Building GMP Excellence: A Guide to Implementing Compliant …
Excel Power Skills: Master Functions, Formulas, and Macros …