Building a quality system that holds up under FDA and ISO audits takes more than a template. This 60-minute webinar gives a step-by-step guide and checklist for setting up a quality system for FDA-regulated products, drawn from first-hand experience with medical device, pharma, dietary supplement and cosmetic companies.
You'll learn how FDA quality system requirements apply to your product, the basic documentation you need, and which requirements are unique to each industry and which are common to all FDA-regulated products. The session also covers internal training and supplier management records, preparing for audits, and key FDA and ISO references and where to find details for your products.
WHY SHOULD YOU ATTEND?
Knowing which quality system items are mandatory and which are nice to have helps you build a strong system and keep good records as proof of compliance. It is especially useful when adding products such as a drug-coated device that must meet both device and drug requirements.
This session suits quality directors and managers, regulatory professionals, QA/QC and production staff, senior leaders, and people moving into cosmetic or supplement companies from food, device or pharma.
AREA COVERED
- FDA quality system requirements for your product
- Basic quality system documentation
- Requirements unique to each industry and those common to FDA-regulated products
- Understanding requirements and preparing for audits
- Internal training and supplier management documentation
- Key FDA and ISO references and where to find information for your products
LEARNING OBJECTIVES
- Explain FDA quality system requirements for your product
- Identify basic quality system documentation needs
- Separate industry-specific requirements from those common to all FDA-regulated products
- Prepare your quality system for FDA and ISO audits
- Plan training and supplier management documentation
- Find key FDA and ISO references 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
Knowing which quality system items are mandatory and which are nice to have helps you build a strong system and keep good records as proof of compliance. It is especially useful when adding products such as a drug-coated device that must meet both device and drug requirements.
This session suits quality directors and managers, regulatory professionals, QA/QC and production staff, senior leaders, and people moving into cosmetic or supplement companies from food, device or pharma.
- FDA quality system requirements for your product
- Basic quality system documentation
- Requirements unique to each industry and those common to FDA-regulated products
- Understanding requirements and preparing for audits
- Internal training and supplier management documentation
- Key FDA and ISO references and where to find information for your products
- Explain FDA quality system requirements for your product
- Identify basic quality system documentation needs
- Separate industry-specific requirements from those common to all FDA-regulated products
- Prepare your quality system for FDA and ISO audits
- Plan training and supplier management documentation
- Find key FDA and ISO references 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