COURSE ID 3014

Data Integrity

One Part of the FDA Inspection Readiness Certification

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Danielle DeLucy, M.S.

Price
$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report.

To this end, in this accredited course, we will discuss effective batch record review. Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in current Good Manufacturing Practices (CGMP) for US Food and Drug Administration (FDA)-regulated industry.

Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. The reasoning behind this complex issue is quite simple: if the integrity of laboratory data is compromised, batches of finished goods may not comply with regulatory authorization terms and, consequently, will not be released for sale.

Upon completion of this course, participants will be able to:

  • Describe the current regulatory position on data integrity
  • Discover the criteria for data integrity
  • Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
  • List approaches to improve data integrity in a laboratory environment
  • Address Part 11 compliance
  • Discuss FDA citations related to data integrity issues

This training is part of a 10 course (15 hour) series required for the FDA Inspection Readiness Certification. Attend this training as a step in the certification process or as a stand-alone course for personal career advancement and training.

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This course will be valuable to all individuals working within or managing a manufacturing program that supports either the R&D development of a new drug product or the manufacture of commercial drug product released to the market and would be beneficial to professionals in:

  • Quality Control
  • Quality Assurance
  • Technical Operations
  • Contract Manufacturers
  • Manufacturing and Filling Operations
  • Research & Development

Regulatory affairs personnel as well as individuals who are responsible for the review or audit of such inspections and reports would likewise find this course very worthwhile.

 

Course Instructor

Danielle DeLucy, M.S.

Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, M.S.’s Courses
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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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