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.
California Meal and Rest Breaks: What You Dont Know Can Cos…
Responding to EEOC Discrimination Charges-What's Your Busin…
Implementing an Effective Human Error Reduction Program
Conflict Resolution - Prevent, De-escalate, Resolve
When Employees Travel: Wage and Expense Rules Employers Mus…
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Female to Female Hostility @Workplace: All you Need to Know
Form 1099-MISC and 1099-NEC Compliance Update 2024
Validation Statistics for Non-Statisticians
The Totally Organized Professional Is All About Outcomes
Why EBITDA Doesn't Spell Cash Flow and What Does
GAMP5, Second Edition and Alignment with Computer Software …
Project Management for Non-Project Managers - Scheduling yo…
Sunshine Act Reporting - Clarification for Clinical Research
Understanding the Math of HR… So You Can Show How HR Impact…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
How to Address ISO's New Climate Change Requirements
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
How To Conduct An Internal Harassment And Bullying Investig…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Managing Toxic & Other Employees Who Have Attitude Issues
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Do's and Don'ts of Giving Effective Feedback for Performanc…
Onboarding New Hires: Leverage the Potential of Artificial …
Project Management for HR, Administrative Professionals, an…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Using Behavior Based Interviewing for Finding the Best Matc…
How to Document Employee Discussions and Why it is Important
Stressed Out: How to Handle Conflict, Difficult People and …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Best Practices for Working With Vendors and Suppliers
Understanding the Artificial Intelligence Landscape
Marketing to Medicare or Medicaid Beneficiaries - What You …
Accounting For Non Accountants : Debit, Credits And Financi…
Principles & Practices for the Cybersecurity of Legacy Medi…
Independent Contractor vs. Employee New Rule Issued by The …
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Kicking your Employee Retention Efforts into Overdrive: Sta…