ComplianceOnline

Ensuring Integrity and Security of Laboratory Data

Instructor: Dr. Ludwig Huber
Product ID: 702454
  • 8
  • March 2017
    Wednesday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 75 Min

Live Online Training
March 08, Wednesday 10:00 AM PST | 01:00 PM EST
Duration: 75 Min

$229.00
One Dial-in One Attendee
$499.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

recorded version

$279.00
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

$379.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days after completion of Live training

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.

Why Should You Attend:

The FDA has found and reported multiple cases where companies manipulated electronic laboratory records to bring out-of-specification results into specifications. Since then FDA inspectors have focused during GLP, GCP and GMP inspections on security, availability, accuracy and integrity of 'complete' laboratory records. The FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors.

In the last three years alone, the FDA issued over 30 warning letters and 483 form inspectional observations related to electronic records. The industry is unsure how to comply with FDA inspection requirements.

This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.

Complimentary Hand-outs:

For easy implementation, attendees will receive

  • SOP: Integrity and Security of Electronic Laboratory Data.
  • Checklist: Security and Integrity of Electronic Data.
  • SOP: Electronic Audit Trail - Specification, Implementation, Validation.
  • 10 Case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions.

Areas Covered in the Webinar:

  • Eight key FDA/EU requirements for integrity and security of laboratory data.
  • How FDA inspectors check integrity and security of data.
  • Most frequent security and integrity issues: going through recent 483's, EIRs and warning letters?
  • The importance of limited access to 'individual users' rather than to groups.
  • FDA compliant definition, acquisition, maintenance and archiving of raw data.
  • Critical integrity and security issues during the entire life of laboratory data: fromĀ  data acquisition through evaluation to archiving.
  • Examples how to ensure and document data integrity.
  • Documenting changes of laboratory data: paper, hybrid systems, electronic.
  • The importance of electronic audit trail to document data integrity.
  • Review of electronic audit trail: who, what, when and how.
  • Ensuring timely availability through validated back-up and archiving.
  • Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions.

Who Will Benefit:

  • All companies generating laboratory records in regulated environments
  • Pharmaceutical and Device Manufacturers
  • API Manufacturers
  • Contract Laboratory Organizations providing services for GxP compliance
  • Documentation professionals
  • QA/QC managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Training departments
  • Consultants
Instructor Profile:
Dr. Ludwig Huber

Dr. Ludwig Huber
Director and Chief Editor, Labcompliance

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. Dr. Huber is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.

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