eCTD Focused Microsoft Word and PDF Document Creation Workshop

6.0
RAC Credits
Virtual ProgramsVirtual Programs
Tuesday, 06 December 2022 (9:00 AM) - Tuesday, 06 December 2022 (3:00 PM) Central Time (US & Canada)

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 …

  • Need to create a Word document that will produce a PDF file that is over 95% compliant with the touch of a button
  • Need to ensure your documents meet the technical specification requirements
  • Need a better understanding of the use of custom styles versus templates
  • Want to learn different strategies and tips for troubleshooting tricky formatting
  • Want to learn document organization strategies
  • Learn how to most effectively use versioning and file naming conventions
  • Or, just need to know how you can accomplish these goals without purchasing templates ... then this course is for you.

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.


Pricing Amounts and Deadlines

Before 6 November 2022: Member $495 | Nonmember $580
After 6 November 2022: Member $580 | Nonmember $680


Learning Objectives

During this workshop, you will learn:

    Word:
  • How to create your own custom basic style set, including headings, headers, Tables of Contents, captions, and tables
  • How to incorporate formatting to automatically generate bookmarks and hyperlinks when rendered to PDF
  • How to create and apply CTD or other numbering format to headings
  • How to effectively create and insert table/figure/appendix captions and hyperlinked cross-references
  • How to create unconventional captions using custom numbering
  • How to ensure your Word file consistently renders properly to PDF (avoiding awkward page breaks, hyperlink errors, non-landscaped headers, tables split across pages, incorrect TOC numbering, missing entries in TOCs/lists of tables and figures, etc.)
    PDF:
  • How to generate eCTD-compliant PDF files
  • How to effectively organize and combine multiple files into a single PDF
  • How to remediate flattened or scanned PDF files
  • How to QC and correct formatting issues in PDF
  • How to effectively convert Excel spreadsheets to PDF

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.


Instructors:

Susana de Azevedo

MARIANNE MOWRER

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.

Eric Klasen

NORA KEELING

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.


Cancellation Policy

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 raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@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

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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