In the current environment of global standardization of quality and regulatory needs, learning to understand and interpret the FDA regulatory requirements for medical device and pharmaceutical companies has become overly complicated for Quality personnel, manufacturing and product design engineers. However, setting up a bullet proof FDA compliant quality management system is an important step for product registrations and later on for passing FDA audits. This webinar will provide a step by step approach and valuable tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies.
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
Why Should You Attend
To fulfill the ever growing, complex quality and regulatory requirements to manufacture, register and launch your medical device or pharmaceutical product in a timely manner by setting up a good quality System.
Learn how to approach setting up a quality system for a diversified product that needs to fulfill pharmaceutical and medical device requirements in the FDA quality arena.
How focusing on getting the ISO certification is the best marketing strategy to launch a product as it will automatically make you ready for the unannounced FDA inspections.
Understanding ISO13485:2016 requirements and setting up your Quality Management System (QMS) per ISO requirements will be a key step for introducing your novel medical product and making your quality system FDA audit ready.
This presentation will provide a step by step approach to setting up a bullet proof quality management system (QMS) for your medical products.
This presentation will be useful to you if you are a virtual manufacturer or if you are manufacturing your product on site.
Strategically prioritizing and fulfilling the regulatory and quality requirements mandated under 21 CFR 820 for medical device regulations and seamlessly adding FDA’s 21 CFR 210 for cGMP manufacturing, 21 CFR 211 for finished pharmaceuticals will be clearly outlined in this webinar presented by someone who has experience in setting up QMS.
What seems like a maze to professionals who are non-medical device and non-pharma auditors at the beginning, will begin to make sense after attending this valuable presentation.
- Will review FDA expectations based on her personal experience in setting up Quality Systems ( QS) in Pharma and device companies
- Will incorporate several examples based on the FDA Requirements for setting up quality systems so you can integrate them into your company SOPs
- Will discuss pathways for successfully interpreting regulatory expectations for medical devices, pharmaceutical quality management systems
- Will educate you on practically dealing with quality system setup needs for medical devices, pharmaceutical companies
- Share FDA expectations for quality systems from 1st hand experience with QS in several FDA regulated companies
- Will share many practical examples from which you can lay a strong foundation for successfully setting up your FDA complaint pharma / device quality system
- You will learn the step by step approach for setting up your quality system , prevent mistakes and avoid FDA 483s during audits and also get ISO certified
Who Will Benefit
- Quality engineers and Inspection engineers
- Manufacturing Engineers in FDA regulated Pharma and Device Companies
- Quality Auditors
- Quality Managers
- Quality Directors and VPs in FDA regulated Pharma and Device Companies