Webinar Ensuring Data Integrity for FDA/EU Compliance

Description :

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. Just in the last three years 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. Because of missing clear guidance from the FDA the industry has lots of questions. Using recent warning letters as examples, this seminar will demonstrate how current data integrity requirements will be identified, implemented and documented.

For easy implementation, attendees will receive

SOP: Integrity and Security of Electronic Records

SOP: Review of Electronic Audit Trail

Checklist: Security and Integrity of Electronic Data for Part11/Annex 11 Compliance

Areas Covered in the Session :

Eight key FDA/EU requirements for integrity and security of electronic records

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 of data through validated back-up and archiving

Required skills and responsibilities of internal and 3rd party consultants?

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

Who Will Benefit:

Everybody using computers in FDA regulated environments

IT managers and staff

Manufacturers of drug substances (APIs)

Medical Device Manufacturers

Analytical Contract laboratories

Clinical contract laboratoriers

QA managers and personnel

Quality control directors or delegates

Internal auditors

Regulatory affairs

Training departments

Consultants

Validation specialists

Price tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1455