Falls Church, VA (PRWEB) February 04, 2015
If the Subject Matter Experts are stressed out now … then get ready for what's to come.
FDA’s new plans to create specialized teams of investigators — their composition and expertise based on specific products — are going to put more pressure on SMEs than ever before. Are the SMEs ready?
It's not just about logistics any more — how the investigator is greeted at the front door, should he/she be offered a glass of water or how many copies of key documents to make. The stakes are much higher.
Don’t miss FDAnews’ newest webinar, FDA’s New Inspectorate Re-Org to Put Pressure on SMEs, on Monday, February 23.
In just 90 minutes, attendees will learn best practices and key points to ensure that SMEs are fully prepped to address questions from the new specialized inspection teams.
Attendees will be taught the fine points of how to develop a comprehensive strategy based on assessed risks and train SMEs to address these risks with the investigation team. Attendees will learn such specifics as how to:
- Ensure that SMEs are aligned to the topics they are going to be asked the most
- Improve SME effectiveness by conducting thorough simulated inspection scenarios
- Satisfactorily answer questions commonly asked by investigators
- Avoid providing “extra information” that was not required to answer a question
- Successfully push back against FDA investigators' requests for documents
- Avoid angry responses, body language and tone of voice that can derail interviews
- And much more
Meet the Presenter:
Joanne Cochran is President of JWC Training Associates and 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. Her expertise includes delivery of diverse regulatory and technical programs at both domestic and international sites.
Who Will Benefit:
- Compliance personnel
- Regulatory affairs professionals
- QA/QC personnel
- Potential SMEs for inspection
FDA’s New Inspectorate Re-Org to Put Pressure on SMEs
Feb. 23, 2015 — 11:30 a.m. – 1:00 p.m. EST
$487 per site -- includes webinar registration and audio cds and transcripts
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.