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Webinar On Learning from Recent FDA Warning Letters related to Part 11 and Computer Validation

Event Details

Webinar On Learning from Recent FDA Warning Letters related to Part 11 and Computer Validation

Time: May 7, 2015 from 1pm to 2:15pm
Location: Canada
Street: 5939 Candlebrook Court
City/Town: Mississauga, ON
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Apr 16, 2015

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Event Description

Description :

Some time ago FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of most inspection. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings and inspectors regularly cited deviations related computer to validation and other Part 11 issues. 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 Part 11 requirements will be met.

For easy implementation, attendees will receive

Checklist: Part 11 compliance

Case Studies: How to avoid Part 11 related 483's and Warning Letters

SOP:  Electronic Audit trail: Specifications, Implementation, Validation

Areas Covered in the Session :

FDA inspections: Preparation, conducts, follow up

The meaning of warning letters and 483 inspectional observations

Learning from an FDA presentation: “Data Integrity and Fraud - Another Looming Crisis?”

Data integrity and authenticity: FDA's new focus during inspections

Examples of recent Part 11 related 483’s and Warning Letters

Examples of recent 483’ and warning letters related to computer system validation

Most obvious reasons for deviations

Avoiding and responding to 483: going through case studies

Writing corrective AND preventive action plans as follow up to 483's

Using internal audits to prepare yourself for Part 11 related FDA inspections

Strategies and tools for compliant Part 11 implementation

The future of Part 11and computer system validation

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

Regulatory affairs

Training departments


Validation specialists

Price tags:


Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899


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 :

For more information about this event please visit

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