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.
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.
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:
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.
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:
Edwin Waldbusser
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.
Strategies For Job Seekers: Best Practices For A Strategic …
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Excel - Reporting Simplified - Learn Pivot Tables from Scra…
Turning Workplace Conflict into Positive Connection
Retention Starts Here: Stop Losing Your Critical Talent and…
Project Management for Non-Project Managers - How to commun…
The Business Case for LGBTQIA+ Inclusion in the Workplace: …
AI and Human Resources: The Great Opportunity!
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
AI-Powered Change Leadership Operationalizing AI: Practical…
Cyber Security Incident Response Team Training Program
Excel Power Skills: Master Functions, Formulas, and Macros …
Transforming Anger And Conflict Into Collaborative Problem …
The Courage to Speak: Overcoming Fear and Owning the Room
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Finance & Accounting 101 Simplified
6-Hour Virtual Boot Camp on Microsoft Power BI
Developing an Agile Workforce with Emotional Intelligence (…
Compliance Under Fire: Navigating I9 Immigration Raids & …
FDA Regulation of Artificial Intelligence/ Machine Learning
Empowering Conflict Resolution: Letting Go to Gain Control
Human Error Reduction Techniques for Floor Supervisors
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
Secrets Of Psychology - Why People Do The Things They Do
How To Conduct An Internal Harassment And Bullying Investig…
Leadership: Strategic Planning and Decision Making
Marketing to Medicare or Medicaid Beneficiaries - What You …
Polish your Presence on Linkedin - The Powerful Profile
Utilizing A Proven Process When Conducting Sensitive, Inter…
Bootcamp for New Managers and Supervisors: Develop These Es…
Leveraging Artificial Intelligence in HR