Online Webinar :Ensuring Data Integrity for FDA/EU Compliance By Dr. Ludwig Huber

Website http://c2gowebinars.com/product/?topic=ensuring-data-integrity | Edit Freely

Category

Deadline: July 14, 2016 | Date: July 14, 2016

Venue/Country: Online, U.S.A

Updated: 2016-06-09 16:43:16 (GMT+9)

Call For Papers - CFP

FDA has found and reported about multiple cases where companies manipulated electronic records. Since then FDA inspectors have focused inspections on security, availability, accuracy and integrity of 'complete' records. FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors. The industry is unsure how to comply with FDA inspection requirements.

Learning Objectives :

Key FDA/EU requirements for integrity and security of electronic records

Key points of the FDA Guidance: Data Integrity for CGMP Compliance

How FDA inspectors check integrity of data

Most frequent data 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 records

Examples how to ensure and document data integrity

Documenting changes of regulated 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

Required skills and responsibilities of (3rd party) consultants?

Going through 10 representative case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions

Handouts:

For easy implementation, attendees will receive three SOPs

Integrity and Security of Electronic Records

21 CFR Part 11 - Scope and Controls

Electronic Audit Trail - Specification, Implementation, Validation

Who will Attend :

Laboratory managers and staff

Operators of computer systems

IT administrators

QA/QC managers and personnel

Regulatory affairs

Training departments

Documentation department

Consultants

Validation specialists

Who will benefit :

Small, midsize and large pharmaceutical companies

API manufacturers

Medical device companies

Contract laboratories

CROs

Webinar includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

75 Minutes Live Presentation

Certificate of attendance

For Registration :http://c2gowebinars.com/product/?topic=ensuring-data-integrity

Note: Use coupon code    and get 15% off on registration.