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Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Are you a technical or clinical author in need of a less frustrating way to format Word files? Are you a document preparer and need to produce consistently formatted documents? Do you need to generate CTD-compliant PDF files for regulatory submissions? If you already have a solid working knowledge of Microsoft Word and …
Well organized, consistently formatted documents are the key to creating submissions which are easy to read and review. Poorly constructed documents are often viewed as a lack of attention to detail. No one wants a reviewer to think this lack of attention may extend to the document content as well. Our goal in this workshop is to help you use non-template-based formatting to your best advantage.
Before 6 November 2022: Member $495 | Nonmember $580
After 6 November 2022: Member $580 | Nonmember $680
During this workshop, you will learn:
Join us for this essential one-day workshop led by industry professionals who can offer training, tips, tricks and best practices gathered from over 20 years of experience.
Marianne: eSubmission Services, Inc., as well as Mentara, Inc., and other consulting groups. She has 20+ years’ experience preparing documentation and regulatory submissions for domestic and international pharmaceutical and biotechnology industries. She has successfully compiled and submitted over 1,000 submissions to multiple Regulatory Agencies, all without a single refuse-to-file. Her group enjoys an exceptional record of meeting critical deadlines, and for streamlining and managing the complex process of document creation from multiple authors and contributors, and generation of Agency-compliant PDF files for submission.
Nora: has over eight years of experience in regulatory operations and FDA submissions Quality Control (QC), including hands-on experience with numerous CTD and eCTD submissions. She works as an independent consultant with her own team, Professional eSubmission Services Inc., as well as part of the Mentara, Inc. consortium. She has participated in the successful project management, document processing, compilation and submission of numerous eCTD sequences. Nora is responsible for formatting QC, ensuring documents meet regulatory specifications, as well as submission compilation QC.
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 firstname.lastname@example.org. RAPS is unable to accept cancellations by phone.
To transfer a registration, email email@example.com with the event title, name of the original registrant and the contact information for the new attendee.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-helpFor account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email firstname.lastname@example.org.