In this 60-minute webinar on “Setting up a Quality System for FDA Regulated Products: Tips and Tricks for your Regulatory Compliance” the presenter will provide a step-by-step guide and Checklist for the attendees. The presenter who has personally participated in setting up from scratch or improving existing Quality Systems (QS) for Medical Devices, Pharma, Dietary supplements, and Cosmetic Companies will share her firsthand experience with regulatory expectations. Items that are unique to each industry will be highlighted so that the attendees can build up QS that will withstand scrutiny by FDA and ISO Auditors.
WHY SHOULD YOU ATTEND?
This webinar is extremely useful as Information on mandatory and nice-to-have items for your QS will be discussed so you can use the practical tips provided here for creating a bulletproof quality system for your company or as part of your ongoing continuous improvement of your QS and maintain excellent documentation as proof of your Quality Management System for regulatory compliance.
This webinar will be extremely useful for Committed Quality professionals and their management in understanding quality expectations as one adds on new products such as a drug-coated device which will need to follow most of the Medical Device and Drug Compliance needs.
In addition, folks who transition into a Cosmetic or Dietary supplement manufacturing company from a food or medical device/ pharma company will be able to successfully navigate into setting up a bulletproof Quality System.
AREA COVERED
- Understanding FDA Requirements for your product in terms of quality system (QS)
- Basic QS documentation needs
- QS Requirements that are unique to each industry and those that are common to FDA-regulated products
- Understanding the requirements and preparing for Audits
- Internal training and supplier management documentation needs for FDA-regulated products
- Details and key references to FDA and ISO requirements and where to get the basic information needed for your products
LEARNING OBJECTIVES
- Understanding FDA Requirements for your product in terms of quality system (QS)
- Basic QS documentation needs
- QS Requirements that are unique to each industry and those that are common to FDA-regulated products
- Audit readiness
- Training needs
- References to key FDA and ISO requirements and where to get the details needed for your products
WHO WILL BENEFIT?
- Quality Directors and Managers
- Regulatory Professionals
- QA/QC and Production Supervisors and Employees
- Upper Management leaders who want to understand the need to prioritize Quality resources
This webinar is extremely useful as Information on mandatory and nice-to-have items for your QS will be discussed so you can use the practical tips provided here for creating a bulletproof quality system for your company or as part of your ongoing continuous improvement of your QS and maintain excellent documentation as proof of your Quality Management System for regulatory compliance.
This webinar will be extremely useful for Committed Quality professionals and their management in understanding quality expectations as one adds on new products such as a drug-coated device which will need to follow most of the Medical Device and Drug Compliance needs.
In addition, folks who transition into a Cosmetic or Dietary supplement manufacturing company from a food or medical device/ pharma company will be able to successfully navigate into setting up a bulletproof Quality System.
- Understanding FDA Requirements for your product in terms of quality system (QS)
- Basic QS documentation needs
- QS Requirements that are unique to each industry and those that are common to FDA-regulated products
- Understanding the requirements and preparing for Audits
- Internal training and supplier management documentation needs for FDA-regulated products
- Details and key references to FDA and ISO requirements and where to get the basic information needed for your products
- Understanding FDA Requirements for your product in terms of quality system (QS)
- Basic QS documentation needs
- QS Requirements that are unique to each industry and those that are common to FDA-regulated products
- Audit readiness
- Training needs
- References to key FDA and ISO requirements and where to get the details needed for your products
- Quality Directors and Managers
- Regulatory Professionals
- QA/QC and Production Supervisors and Employees
- Upper Management leaders who want to understand the need to prioritize Quality resources
Speaker Profile

Meena Chettiar completed her education in India, Canada, and the United States where she completed master’s degrees in applied chemistry, Chemical Engineering, and Regulatory Affairs for Medical devices respectively. Meena has worked for Health Canada and Agriculture Canada as a Scientist and Quality Control Chemist. After immigrating to the United States Meena worked for Land O’Lakes and key Pharmaceutical and Medical device Companies such as Cephalon, Baxter, and Covidien in Minnesota, USA. Meena recently transitioned from serving as a Quality Director for Welly Health to the Head of Quality at a Cosmetic Company in the DC area.Meena currently also serves …
Upcoming Webinars

Transform Data into Insights: A Beginners Guide to Excel Pi…

Leadership: Strategic Planning and Decision Making

Onboarding Best Practices for 2025: Proven Strategies to Po…

Seeking Truth: Detecting Truth, Lies and Deception in a Wor…

Managing Difficult Employee Conversations

Copilot and HR: An Introduction for HR Professionals

How to Document Employee Discussions and Why it is Important

Dealing With Difficult People In Life & Work

How to Write Effective Audit Observations: The Principles f…

OSHA Requirements for Supervisors, Project Leaders & HR - W…

FDA Compliance And Laboratory Computer System Validation

4-Hour Virtual Seminar on Transformational Leadership - The…

3-Hour Virtual Boot Camp on Easier Excel Automation with VB…


2025 Handbook Overhaul: Navigating Critical Updates! Federa…

Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…

Negotiating Skills For Professional Results - Winning Strat…

Building Thriving Teams: Proactive Strategies for Managers …

Designing Employee Experiences to Build a Culture of Compli…

Empowering Conflict Resolution: Letting Go to Gain Control

Navigating Alcohol and Drug Addiction Protections Under the…

President Trumps Executive Orders And What They Mean to Emp…

The Anti-Kickback Statute: 2025 - Year in Review

FDA Technology Modernization Action Plan (TMAP) and Impact …

Form W-9 Compliance: TIN Verification, B Notices, and Avoid…

Workplace Investigations 101: How to Conduct your Investiga…

50+ new Excel features so far this decade


FDA Regulation of Artificial Intelligence/ Machine Learning

From Challenges to Compliance: Understanding Dietary Supple…

Utilizing HR Metrics to Illustrate & Improve Human Resource…

Do's and Don'ts of Documenting Employee Behaviour, Performa…


The Importance of the first 5 seconds when presenting

Why EBITDA Doesn't Spell Cash Flow and What Does

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…


Impact Assessments For Supplier Change Notices

The Monte Carlo Simulations in Excel for Risky Investments

Understanding the incredible uses and fallbacks of ChatGPT

California Meal and Rest Breaks: What You Don't Know Can Co…

Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…


Onboarding is NOT Orientation - How to Improve the New Empl…


Gossip-Free: Leadership Techniques to Quell Office Chatter

Female to Female Hostility @Workplace: All you Need to Know


6-Hour Virtual Seminar on Learning the Highlights of Excel …