In this webinar, you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one. You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, and how personnel should conduct themselves during the inspection, the inspection process and how to respond to 483s and warning letters. How to respond and when is critically important. Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them.
WHY SHOULD YOU ATTEND?
FDA will inspect you! Are you ready? FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483s than a disorganized company. If a 483 is received knowing how to respond will lessen the chances of receiving a Warning Letter.
LEARNING OBJECTIVES
- Personnel preparation
- Procedure to follow during audit-what to do/ what not to do
- Facility requirements to support inspection
- Behavior during inspection-what not to sign
- Internal/ mock audits
- 483/ Warning Letter response
WHO WILL BENEFIT?
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, fields. The employees who will benefit include:
- Executive/senior management
- Regulatory management
- QA management
- Any person who may have direct interaction with FDA officials
- Consultants
- Quality system auditors
- Quality Engineers
- Compliance Specialists
- Compliance Leaders
- CAPA Specialists
- Management Representatives
- Compliance Managers and Directors
- Quality Managers and Directors
- Consultants and Contractors
FDA will inspect you! Are you ready? FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483s than a disorganized company. If a 483 is received knowing how to respond will lessen the chances of receiving a Warning Letter.
- Personnel preparation
- Procedure to follow during audit-what to do/ what not to do
- Facility requirements to support inspection
- Behavior during inspection-what not to sign
- Internal/ mock audits
- 483/ Warning Letter response
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, fields. The employees who will benefit include:
- Executive/senior management
- Regulatory management
- QA management
- Any person who may have direct interaction with FDA officials
- Consultants
- Quality system auditors
- Quality Engineers
- Compliance Specialists
- Compliance Leaders
- CAPA Specialists
- Management Representatives
- Compliance Managers and Directors
- Quality Managers and Directors
- Consultants and Contractors
Speaker Profile
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
Upcoming Webinars
Documenting Misconduct that Will Stand Up in Court
Sunshine Act Reporting - Clarification for Clinical Research
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Stress, Change And Team Resilience Through Humor: An Intera…
Managing Toxic & Other Employees Who have Attitude Issues
FDA Regulation of Artificial Intelligence/ Machine Learning
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Pharma 4.0: Next Generation Technology Approach to GxP Prod…
Patient Gifts, Discounts and Freebies: What You Can and Can…
Managing Complex Projects - Project Management
All About Civility - Eliminating a Culture of Gossip Rumors…
From Challenges to Compliance: Understanding Dietary Supple…
Using Behavior Based Interviewing for Finding the Best Matc…
Improving Employee Engagement & Retention Through Stay Inte…
How To Conduct An Internal Harassment And Bullying Investig…
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
Leadership: Strategic Planning and Decision Making
De-Stressing Your Leadership for Greater Impact
The Anti-Kickback Statute: Enforcement and Recent Updates
Emotional Intelligence: Mastering the Emotions of Great Lea…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
How to Conduct Exit Interviews - Implementing and Enhancing…
Finance & Accounting 101 Simplified
Understanding How To Write A Compliant CAPAs
4-Hour Virtual Seminar on Transformational Leadership - The…
Selecting Right Vendors And RFP Drafting
Uplifting the Credibility of HR: How to Build the Credibili…
Courts No Longer Have to Give Deference to Agency’s “Expert…
Treasury Risk Management, Funding, Liquidity, Interest Rate…
21 CFR Part 820 - Quality System Regulation - Applying Prin…
Building GMP Excellence: A Guide to Implementing Compliant …
Building Fair Chance Hiring Policies in 2024
FDA Technology Modernization Action Plan (TMAP) and Impact …
21 CFR Part 11 - Compliance for Electronic Records and Sign…
How to Survive an Emotionally Toxic Workplace
How to Give Corrective Feedback: The CARE Model - Eliminati…
SOPs - How to Write Them to Satisfy those Inspectors
Excel Power Skills: Master Functions, Formulas, and Macros …
Essential Job Functions According to the American with Disa…
Understanding the Artificial Intelligence Landscape