Course Description:
There is no doubt that data integrity is the current and future inspection focus of all regulatory heath care agencies. More than 50% inspection reports such as 483's and Warning Letters quote data integrity as deviations from GxP regulations.
This new 2-day course provides the regulatory background and guides attendees through the complete record lifecycle from data entry or acquisition through evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA's Part 11 and the EU/PICS Annex 11.
The 2-day course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.
Learning Objectives:
Attendees will:
- Understand what data integrity is and why it is so important for public health
- Learn why there are so many data integrity issues
- Learn about the FDA/EU/PICS/MHRA/WHO requirements for data integrity
- Understand how to define and archive raw data from hybrid systems: electronic vs. paper
- Be able to specify and validate Part 11 compliant software functionality
- Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
- Understand FDA's New and ongoing Part 11 inspection and enforcement practices
- Learn how to develop and implement corrective and preventive action plans in response to inspection reports
- Learn how to avoid and/or respond to FDA inspectional observations and warning letters
- Learn how to prevent and detect data integrity issues
Additional Bonus Material for easy implementation
(all available as Web download )
- 43-page primer “Electronic records, electronic signatures” (authored by Dr. Ludwig Huber)
- 10 SOPs related to data integrity, data security and validation of computer systems and data
- Checklists related to Annex 11, Part 11 and data integrity
Who will Benefit:
- QA managers and personnel
- Laboratory managers and supervisors
- Production managers and supervisors
- Analysts
- IT/IS managers and system administrators
- Software developers
- Regulatory affairs
- Training departments
- Documentation departments
- Consultants
Companies and departments:
- Pharmaceutical development and Quality control laboratories
- Quality control laboratories of API manufacturers
- Medical device companies
- Contract laboratories
- Clinical Research Organisation
- Suppliers and service providers of instruments and computer systems
Course Outline:
Sessions indicated with (*) include one or more workshop exercises
Day One (8:30 AM - 4:30 PM) | Day Two (8:30 AM - 4.30 PM) | ||
8:30 AM - 9:00 AM: Registration Process 9:00 AM: Session Start Day 1 – Lectures and Workshop Exercises Module 1 Definitions, requirements and approaches for data integrity
Module 2 Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11
Module 3 Strategies to detect and avoid integrity issues
Module 4 The Quality System as Prerequisite for Data Integrity
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Day 2 - Lectures and Workshop Exercises Module 5 Cost effective Validation of software and computer systems
Module 6 Definition and Handling of Raw Data
Module 7 Good documentation practices to ensure data integrity
Module 8 Data Integrity Auditing: Internal and FDA inspections
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- 50 % of the time will be dedicated to workshop type exercises using prepared fill-in templates and to interactive discussions
Meet Your Instructor
Dr. Ludwig Huber Chief Advisor - Global FDA Compliance, Labcompliance
For more information, visit www.ludwig-huber.com/qualification |
Register Now
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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 @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or 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 — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.
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We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
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