Computer System Validation Masterclass

This course has been updated to include the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. Regulatory guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. The course does not aim to cover detailed and highly technical aspects of software and hardware internal engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a Practical validation Approach; Protocols and reports; Vendor selection and approval process; and efficient system lifecycle, Quality Risk Management updated GAMP categories, the role of the supplier, and the selection of appropriate specification (FRS and URS) and verification activities. This Program enhances every participant to obtain a comprehensive knowledge of the basic principles for the validation of computerized systems, the requirements of Part 11 and specific aspects of the validation of computerized systems.

– GAMP 5
– Annex 11
– Warning Letters
– Validation Process
– Vendor Management
– Computer Software Assurance
– Data Integrity
– Group Discussions
– Case Studies
– Certification

Complete Agenda is available in the brochure. Kindly download the brochure

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at info@compliancetrainings.in

Payment Policy:

Payment using Credit/Debit Card: Payment is required to be made at least 3 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.

Payment via Bank Transfer: Registrations by Wire transfers are required to be made at least 5 business days before the date of the conference. Payments to be made in full.

Payment by Check: Registrations by Check payments are required to be made at least 10 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. Payments to be made in full. Post-dated checks shall not be accepted.

Customer Support: +91-80-4170-0521
Email: info@compliancetrainings.in

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund – minus a 20% administration fee. No cancellations will be accepted – nor refunds issued – within 10 calendar days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

Compliance Trainings reserves the right to change/modify some topics, material or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Conference photograph / video:

By registering and attending Compliance Trainings conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to Compliance Trainings using these photos and videos for marketing, archiving or any other conference related activities. You agree to release Compliance Trainings from any kind of claims arising out the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.