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

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

Maximizing Productivity with ChatGPT: AI Solutions for HR, …



2-Hour Virtual Seminar on Empowering Presentations with Pow…

Pivot tables beginner to advanced + 20 advanced Pivot table…

Understanding Artificial Intelligence (AI) & using Chat GPT

Creating Loyal Customers Through Excellent Customer Service

Understanding and Communication New Immigration Policies (2…

Navigating Talent Management and Retention Strategies.

HIPAA is Unsettled – Safe Compliance Strategies

Project Management for Non-Project Managers - Scheduling yo…

How to Prepare For and Host a FDA Inspection and Respond to…

Empowering Conflict Resolution: Letting Go to Gain Control

Onboarding Best Practices for 2025: Proven Strategies to Po…

Navigating 2025 Employment Laws: What Every Employer Needs …


Managing Toxic Employees: Strategies For Leaders To Effecti…

How to Conduct Exit Interviews - Implementing and Enhancing…

Adapting to Change: Strategies for Personal & Team Resilien…

Introduction to Excels Built-In Solver – Advanced Decision-…

How to Manage the Legal Landmine of the FMLA, ADA and Worke…

FDA Technology Modernization Action Plan (TMAP) and Impact …

Design Control for Medical Devices Including Verification/V…

Stress, Change And Team Resilience Through Humor: An Intera…


Developing and Implementing Quality Culture in the Organiza…

GROUPBY and PIVOTBY functions. Pivot table killers?


Negotiating Skills For Professional Results - Winning Strat…

Use the power of AI to turbocharge your MS Excel


Trust in Leadership: Building and Maintaining Trust as a Le…

Conquer Toxic People - Learn To Protect Yourself And Get Yo…

Excel - Pivot Tables - The Key To Modern Data Analysis and …

AI and Human Resources: The Great Opportunity!

Tools and Tactics for Grieving, Surviving, and Thriving in …

Bootcamp for New Managers and Supervisors: Develop These Es…

How To Conduct An Internal Harassment And Bullying Investig…

How Generative AI can be used in Banking Risk and Compliance

Creating Employee Handbooks that Protect You and Support th…

Excel Power Skills: Master Functions, Formulas, and Macros …

Emotional Intelligence: Mastering the Emotions of Great Lea…

Managing Toxic & Other Employees Who Have Attitude Issues


The Five Cs Of Commercial Credit: The Basic Elements Of Cre…

SOPs - How to Write Them to Satisfy those Inspectors

Improving Employee Engagement & Retention Through Stay Inte…


How to Give Corrective Feedback: The CARE Model - Eliminati…