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
Understanding the Artificial Intelligence Landscape
Holiday Stress and Loss: The Art of Stress Resilience in E…
Establishing Appropriate Quality Metrics and Key Performanc…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Is Your Culture Working For or Against Your Success? If You…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Using High-Performance Coaching for Managers to Address Per…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Red flags that can render your OSHA Safety Program Complete…
Transform Data into Insights: A Beginners Guide to Excel Pi…
The Human Element of Leadership in the Hybrid Work Experien…
How to Navigate Political Speech in the Workplace
What If Analysis Tools in Excel: Goal Seek, Solver, and Dat…
Project Management for administrative professionals
3-Hour Virtual Seminar on Chat GPT for Project Management i…
Mastering Year-End Payroll and Tax Compliance for 2024
How to Prepare For and Host a FDA Inspection and Respond to…
Eliminate Harmful And Unproductive Drama In The Workplace
The Anti-Kickback Statute: Enforcement and Recent Updates
FDA Technology Modernization Action Plan (TMAP) and Impact …
5 Key Components of Good Manufacturing Practices to obtain …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Team Synergy: How to Harness Collective Intelligence to Max…
Successful Strategies for FDA Expedited Pathways for Your D…
The Power Of Trust In The Workplace- Improving Your Career …
Managing Toxic & Other Employees Who Have Attitude Issues
Protect Your Company With The End of the Year HR Checklist
Do's and Don'ts of Giving Effective Feedback for Performanc…
So, You’re Now the “Boss”: Essential Skills to Succeed as a…
Onboarding is NOT Orientation - How to Improve the New Empl…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Construction Lending And Real Credit Administration: Evalua…
Building GMP Excellence: A Guide to Implementing Compliant …
Improving Employee Engagement & Retention Through Stay Inte…
4-Hour Virtual Seminar on Transformational Leadership - The…
Understanding cognitive load in medical device design
Human Error Reduction Techniques for Floor Supervisors
Excel Power Skills: Master Functions, Formulas, and Macros …