ComplianceOnline

E-Submissions and Data Standards for FDA (eCTD, CDISC, HL7)

Instructor: Angela Bazigos
Product ID: 704529
  • 13
  • November 2017
    Monday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 90 Min

Live Online Training
November 13, Monday 10:00 AM PST | 01:00 PM EST | Duration: 90 Min

$199.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD free!

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$349.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD/USB

$449.00

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.

Why Should You Attend:

This webinar will provide the new and expected guidances on data standards and electronic submissions for drugs and medical products. We will explain what are the policies and the requirements for submissions and standards for drugs in US and globally and how it affects healthcare/drug industry to adopt them.

This online training will cover FDA’s electronic submission gateway and will alert you regarding some of the problems that are seen with electronic data submissions. Finally, the session will discuss some of the new requirements for electronic submissions to FDA and what you can expect in the future.

Areas Covered in the Webinar:

  • Quality and Product Data Standards
  • Study Data Standards Update
  • Approval Process for Drugs, Biologics and Devices
  • FDA Submission Requirements and Guidances
  • FDA Electronic Regulatory Submission and Gateway
  • e-Submissions, EMEA - EU and Globally
  • International Conference on Harmonization (ICH)
  • Electronic Common Technical Document (eCTD), ICH
  • FDA eCTD Guidance and Specifications
  • Health Level 7 Regulated Clinical Research Information Management
  • Clinical Data Interchange Standards Consortium (SDTM, SEND, ADAM)
  • Biomedical Research Integrated Domain Group (NIH, FDA, CDISC, HL7)
  • Top 10 Issues with Data

Who Will Benefit:

  • Management (pharma, biotech)
  • Policy analysts
  • Government officers
  • Health IT managers and analysts
  • Research and development (pharmaceutical, academia)
  • Regulatory Affairs personnel
  • Quality assurance/quality control personnel
  • Auditors and inspectors
  • Entrepreneurs investors
  • Consultants
  • Regulators
Instructor Profile:
Angela Bazigos

Angela Bazigos
CEO, Touchstone Technologies Silicon Valley Inc

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.

Topic Background:

Each FDA center has different guidelines and processes to follow in order to have a successful submission for the regulatory review of the medical product. The submission process for drugs, biologics and medical devices is rigorous and has specific timelines and standards to follow.

The agencies (FDA, EMEA) encourage electronic submissions and they have developed data standards and other guidelines. The Common Technical Document (CTD) describes the modules, sections and documents to be used by an Applicant for a Marketing Authorization for a medical product for human use ( EU, Japan and US). Different Standard Development Organizations (HL7, ISO, CDISC, ICH) work to produce and harmonize standards nationally and worldwide to improve regulatory submissions.

Follow us :
Upcoming In-person Seminars by EX-FDA OFFICIALS
Risk Management in Medical Devices Industry

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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