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
