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.
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.
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
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
Faculty Meena Chettiar
Director, Quality and Regulatory Affairs at Welly Health PBC
Greater Minneapolis-St. Paul Area
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.
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
Tracey Kessler ( Director of R&D) CEL-SCI Corporation
I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma
The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.