- This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.
- It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation,
- The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
- Understand the specific requirements associated with local and SaaS/cloud hosting solutions.
- Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
- The instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
- Participants will learn how to write a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR).
- This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.
2-Day Virtual Seminar on Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
- Product Id : SEM2083
- Category : Seminar
- Presenter : David Nettleton
- Duration : 2 Days
David Nettleton
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is “Risk Based Software Validation – Ten easy Steps” that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.
DAY 1 : (9 AM – 3 PM)
Introduction to the FDA
- How the regulations help your company to be successful
- Which data and systems are subject to Part 11
21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures
- What Part 11 means to you, not just what it says in the regulations
Avoid 483 and Warning Letters - Explore the four primary areas of Part 11 compliance: SOPs, software product features, infrastructure qualification, and validation documentation
- How SaaS/cloud computing changes qualification and validation
- Ensure data integrity, security, and protect intellectual property
- Understand the current computer system industry standards for security, data transfer, and audit trails
- Electronic signatures, digital pens, and biometric signatures
- SOPs required for the IT infrastructure
- Product features to look for when purchasing COTS software
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents
Includes two 10 minute breaks and a 40 Minute Lunch break
The Five Keys to COTS Computer System Validation
- The Who, What, Where, When, and Why of CSV
The Validation Team
- How to select team members
- How to facilitate a validation project
DAY 2 : (9 AM – 3 PM)
Ten-Step Process for COTS Risk-Based Computer System Validation
- Learn which documents the FDA expects to audit.
- How to use the risk-based validation approach to lower costs.
- How to link requirements, specifications, risk management, and testing.
- Document a computer system validation project using easy to understand fill-in-the-blank templates.
- Based on: “Risk-Based Software Validation – Ten Easy Steps” (Davis Horwood International and PDA – www.pda.org, 2006)
Includes 10 minute Break
How to Write Requirements and Specifications
- Workshop for writing requirements and then expanding them for specifications
How to Conduct a Hazard Analysis/Risk Assessment-Exercise
- Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation
Software Testing
- Reduce testing by writing test cases that trace to elements of risk management.
- How to write efficient test cases
- Point-of-use aids to compliance
Includes a 40 Minute Lunch Break
How to write a Data Privacy Statement
- How to meet the requirements of the EU GDPR.
Includes 10 minute Break
Purchasing COTS Software
- How to purchase COTS software and evaluate software vendors.
Cost Reduction Without Increasing Regulatory or Business Risk
- How to save money
- How to increase quality
- How to increase compliance with less documentation
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 +1-416-915-4458 or email us at info@webinarcompliance.com
Payment Policy:
Payment is required to be made at least 2 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.
To make payment by Wire Transfer, kindly call our Customer Support to assist you with completing your registration. Registrations by Wire are required to be made at least 7 business days before the date of the conference. Payments to be made in full.
To make payment through a check, please draw a check to FutureCorp Consulting INC. (our parent company), and kindly call Customer Support to assist you further. Registrations by Check payments are required to be made at least 12 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. A letter of confirmation (along with an electronic event pass) will be e-mailed to you once payment is received. Payments to be made in full. Post-dated checks shall not be accepted.
Customer Support: +1-416-915-4458
Email: info@webinarcompliance.com
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After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the event venue.
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 at the venue. 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.
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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 $300 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 ($300) 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.
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If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.
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- Login Information with Password to join the session, 24 hours prior to the webinar
- Presentation Handout in .pdf format
- Presentation from the Speaker
- Feedback form
- Certificate of Attendance
- Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
- Presentation Handout in .pdf format
- Certificate of Attendance