Ensuring Integrity and Security of Laboratory Data

Speaker

Instructor: Dr. Ludwig Huber
Product ID: 702454

Location
  • Duration: 75 Min
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.
RECORDED TRAINING
Last Recorded Date: May-2018

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$349.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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: from¬†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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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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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