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Webinar: How to prep your SMEs for new FDA inspection process

webinar description

Training and preparing a company’s leadership team on how the new FDA inspection plan will be rigorous for appointed SMEs, you'll learn industry practices and key points to ensure you have fully prepared the SMEs to address questions from the new FDA specialized inspection teams. It's not just about logistics any more – The stakes are much higher now so don’t be blindsided by the new inspection plan to grill SMEs.

Reasons to attend the webinar:
  • Training and experience expectation to assure SMEs are aligned to the topics they are going to be asked about.

  • Improving SME effectiveness by conducting thorough simulated inspection scenarios.

  • Learn the commonly asked questions by investigators and answers that are typically found satisfactory.

  • Successfully push back against FDA investigators’ request for documents, if they are not needed.

Speakers:
Elite Solutions
Tracy Brooks, Instructional designer
Tracy Brooks is an instructional designer with extensive experience in designing, developing, and delivering effective regulatory GMP compliance training to all levels of personnel within the pharmaceutical and medical device industries. She has more than 22 years quality assurance and validation experience for product design and development for GMP production, commissioning and qualification and validation experience. She worked as a consultant/contractor to support projects on the development for over 50 products for medical device, pharmaceutical and biologics companies. Expertise includes delivery of diverse regulatory, quality system management and technical programs at both domestic and international sites.
22

Aug

2017

1:00 - 2:30 PM
(GMT -4)

(Duration - 90 minutes)

ATTENDANCE FEE - $185.00

WEBINAR HAS ENDED
Organizer: Elite Solutions

Elite Solutions provides training webinars to build professional education. Our goal as a company is to help individuals rise to greater heights in their professional environments through convenient, effective instructional webinars. We work to help you advance the standard in your industry.

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