This online session will study the evolution of FDA thinking over the past 10 years, which can inform today's regulatory and quality professionals on ways to anticipate questions that will lead to audit success.
Presenters will explore the history of regulatory findings for pharmaceuticals and medical devices in the US, compare findings to topics in current warning letters, and explore newly published FDA guidance documents to provide an inner view on current FDA regulatory expectations to guide audit readiness programs for pharmaceutical and medical device registration holders.
Registration Fees & Deadlines
Present – June 16, 2024 Regular Member $150 Non Member $175
June 17, 2024 – July 16, 2024 Regular Member $175 Non Member $200
Learning Objectives
- Participant will use the most current publicly available data on FDA-483 observations, Warning Letters, and recently published FDA guidance documents to see areas of current regulatory focus.
- Participant will be able to identify how the current regulatory focus has changed from over a ten-year history and use this information to anticipate areas of inspectional focus in the future.
- Participant will be able to leverage cues provided via FDA guidance and current FDA and warning letter postings to gain an inner view on the FDA's thinking.
- Using the information presented in this session, the participant will better prepare for upcoming FDA inspections, especially in the program areas of pharmaceuticals and devices.
Who Should Attend?
This session is aimed at any regulatory or quality professional in pharmaceutical or medical device involved in an operations-based role that may face direct contact with an FDA investigator during an inspection. By understanding FDA inspectional priorities, attendees will be able to determine which areas are most likely to be emphasized during an FDA inspection, guiding preparation for, and presentation efforts during, an upcoming inspection.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
Regina Fullin
VP of RA/QA Consulting, Compliance Team, LLC
Regina performs broad-based quality and regulatory consulting to clients in the medical device and pharmaceutical industries. Her focus is to help them achieve ever-increasing compliance to regulations, focusing on FDA and ISO requirements. Within her role at Compliance Team, Regina serves an industry educational function, using technical writing skills to publish relevant and meaningful articles to help life science companies stay current with regulatory changes, industry trends and improve product quality and regulatory compliance. Regina Holds a bachelor’s in biology, and a RAC-Devices credential. She is also a Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and a Certified Manager of Quality-Organizational Excellence (CMQ-OE) with ASQ.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org