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.
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.
Tracy Brooks, Instructional designer at Elite Solutions
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.