Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Join us for a webinar on November 13 for a discussion of the webinar

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

Webinar Takeaway

The speaker 

  • 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 

Overview

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.

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.

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Meena Chettiar

Meena Chettiar

 Meena Chettiar, has worked as a Scientist for Health Canada and as a Quality Management Professional in food, pharmaceutical and medical device industries for over 25 Years in Canada and the United States. During this time Meena has had the opportunity to be audited by the US FDA several times answering questions on OOS. Meena has also performed several ISO audits in the United States and overseas. She is therefore, very proficient in FDA OOS expectations in the FDA regulated industry. Meena holds several certifications in Quality from the American Society for Quality(ASQ). Meena currently works as the Quality and Regulatory Director at Welly Health, a medical device and pharmaceutical manufacturer in Minneapolis. 

Choose a Purchase Options


$289

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session


$389

Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.