FDAnews Announces — Data Integrity: Latest Regulatory Developments and Best Practices Webinar, Jan. 14, 2020

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How does one ensure data integrity? Get the latest developments and best practices by signing up for this webinar today.

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Data Integrity:
Latest Regulatory Developments and Best Practices
An FDAnews/CenterWatch Webinar
Tuesday, Jan. 14, 2020, 1:30 p.m.-3:00 p.m. EST https://www.fdanews.com/dataintegritylatestreg

Is a good quality system in place to ensure data integrity?

The FDA consistently communicates the importance of supporting data integrity. One needs to know when one is required to report significant data integrity issues discovered pre-submission and the advantages of early disclosure to the FDA — even when no early disclosure obligation exists.

Join us for a webinar on Jan. 14 and be ready to tackle any challenges that come up and help companies stay in compliance with the FDA. During the workshop, attendees will:

  • Get an overview of FDA’s expectations for data integrity, including the statutory and regulatory basis for those expectations
  • Review key guidances governing data integrity concepts in both the GMP and GCP context
  • Familiarize oneself with FDA’s recent regulatory actions addressing data integrity issues, including warning letters, import alerts and injunctions
  • Determine best practices to use in responding to questions FDA raises concerning data integrity, such as ensuring a systemic response to deficiencies and using independent third-party auditors
  • Determine the quality by design principles to follow in order to ensure quality and avoid data integrity issues, including identifying key resources

Attendees will gain practical tips for how to build a quality system and gain insight on FDA guidance on data integrity.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Data Integrity:
Latest Regulatory Developments and Best Practices
An FDAnews/CenterWatch Webinar
Tuesday, Jan. 14, 2020, 1:30 p.m.-3:00 p.m. EST https://www.fdanews.com/dataintegritylatestreg

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/dataintegritylatestreg
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
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.

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Michelle Butler
FDAnews
703-538-7600
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