Data Integrity: FDA/EU Requirements and Implementation: 2-Day Workshop by Dr. Huber
Dr. Ludwig Huber, Chief Advisor - Global FDA Compliance, Labcompliance
| Thursday, November 10, 2016 | Friday, November 11, 2016
||Course "Data Integrity: FDA/EU Requirements and Implementation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
- 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
Seminar Fee Includes:
$100 Gift Cert for next seminar
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
- IT/IS managers and system administrators
- Software developers
- Regulatory affairs
- Training departments
- Documentation departments
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
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
Definitions, requirements and approaches for data integrity
- Definition of data integrity: ALCOA+
- The importance of data integrity for public health
- Regulations and guidelines related to data integrity
- Main reasons for non-compliance
- Warning letter statistics by subject and countries
- FDA’s inspection and enforcement strategy of Part 11
- Lessons from recent FDA Warning Letters and how to avoid them
Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11
- Objective, scope, current situation and future of Part11
- Requirements for electronic records
- Requirements for electronic and digital signatures
- Additional requirements from the PICS/EU Annex 11,
- Developing a gap analysis
- Upgrading existing or purchasing new systems:
- Six steps for implementation of Part11/Annex 11
- Examples on how to implement Annex11 and Part11
Cost effective Validation of software and computer systems
- Selecting the right validation lifecycle model
- Going through examples of a complete computer system validation from planning to reporting
- Examples for risk based DQ, IQ, OQ and PQ
- Vendor assessment and supplier agreements
- Validation of existing systems
- Maintaining the validated state: Revalidation vs. periodic review
- Recommendation for network qualification and cloud Computing
Aligning data integrity with the company’s quality system and Code of Conduct
- Contributions to poor quality
- Consequences of poor quality systems
- Recommendations from the FDA
- ICH Q10 – The quality system for pharma industry
- Aligning key requirements with data integrity: e.g., CAPA system, training, internal, audits, risk management and ongoing improvements
- How a Code of Conduct helps to ensure data integrity
- Definition and contents of a related Code of Conduct
Day 2 - Lectures and Workshop Exercises
Definition and Handling of Raw Data
- Definition of Raw Data
- Examples of raw data
- Raw data for paper based and electronic systems
- Criteria for electronic raw data with paper print-outs
- Raw data management along the data lifecycle
- Changing of raw data
- Archiving of raw data from electronic and hybrid systems
- Going through examples
Good documentation practices to ensure data integrity
- Requirements for documentation ( ALCOA+)
- Documents that must be readily available
- Examples for good and bad documentation
- Good practices for paper and electronic data
- How to avoid common documentation mistakes
- The importance of global documentation
- Improving effectiveness through standardization
Strategies to detect and avoid integrity issues
- Recruit, train and retain employees who will be responsible for ensuring data integrity
- Possible causes for data integrity breaches
- Show consequences of data integrity violations
- Understand system vulnerabilities, motivation and likelihood operators might compromise data
- Understand high risks in the data lifecycle
- Formally investigate internal hints about data falsification
- Learning from internal audits and FDA inspections
Data Integrity Auditing: Internal audits and FDA inspections
- Going through a typical FDA inspection as a model for internal audit
- FDA’s new approaches to data integrity inspections
- Typical audit questions
- Identifying systems that must be audited based on risk
- Typical audit findings
- The importance of the exit meeting
- Writing a corrective and preventive action plan to fix data integrity audit findings
- Follow-up on CAPA through verifying effectivess
- 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
Dr. Ludwig Huber, Ph.D., is the chief advisor and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare." He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This includes seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.
Register by P.O. / Check
Yes, I want to attend "Data Integrity: FDA/EU Requirements and Implementation: 2-Day Workshop by Dr. Huber".
Click here to download P.O. form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Palo Alto, CA 94303
Send your team for maximum benefit.
Get your team up to speed!
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
||Get 10% off
|3 to 6 Attendees
||Get 20% off
|7 to 10 Attendees
||Get 25% off
||Get 30% off
Call toll free on +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer, please call us toll free on +1-888-717-2436
Terms & Conditions to Register for the Seminar/Conference/Event
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@example.com
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 $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 or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
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.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
Singapore (Venue to be announced shortly)
November 10-11, 2016
If you wish to partner with us for this event
contact us: firstname.lastname@example.org
call us: +1-888-717-2436.
Media Partner Benefits
- Logo and company data on the event website.
- Logo on the conference material distributed during the conference.
- Media partner’s brochure distributed along with conference material.
- Logo on all the mailings before and after the event.
- 10% discount to media partner's subscribers.
Media Partner To Do
- Banner (min 728x90 or 468x60) on the media partner website.
- Insertion of the event in the event calendar, both printed and/or online.
- Announcement article of the conference on the magazine and/or website.
- Dedicated email blast to media partner’s subscribers.
- Article on the magazine and/or website after the conference.
If you wish to sponsor this event
contact Cruise Webster: email@example.com
call us: (207) 576-4173
Since 1973, Singapore Zoo has been known for having among the most beautiful wildlife park settings in the world, where animals roam freely in open and naturalistic habitats. The Singapore Zoo spans 28 hectares within Singapore's heavily forested central catchment area. The zoo, which attracts about 1.6 million visitors per year, boasts 315 animal species, some of 16% of which are considered threatened species.
The Night Safari is the world's first nocturnal zoo and is one of the most popular tourist attractions in Singapore. Today, the award-winning park welcomes more than 1.1 million visitors a year. They come from all over the world to enjoy the unique experience of seeing over 2,500 animals in their naturalistic nighttime habitats.
Universal Studios Singapore
Universal Studios Singapore is the first and only theme park in Southeast Asia. Go beyond the screen and Ride The Movies™ at Universal Studios Singapore. Only here can you experience cutting-edge rides, shows, and attractions based on your favorite blockbuster films and television series, including TRANSFORMERS The Ride: The Ultimate 3D Battle, Shrek 4-D Adventure, Madagascar: A Crate Adventure, Jurassic Park Rapids Adventure, and more!
The Singapore Flyer is a giant Ferris wheel in Singapore that was constructed between 2005 and 2008. Described by its operators as an observation wheel, it reaches 42 storeys high, with a total height of 165 m (541 ft), making it the world's tallest Ferris wheel, 5 m (16 ft) taller than the Star of Nanchang and 30 m (98 ft) taller than the London Eye.
Underwater World, Singapore
Underwater World, Singapore is Asia's largest tropical oceanarium and one of Singapore's most popular tourist attractions. Opened in 1991, it has more than 2,500 marine animals of 250 species from different regions of the world. It is also involved in several environmental and educational projects, such as the Living in the Ocean Programme, Ocean Ambassador Programme and the Coral Club.
Boat Quay is a zone offering an eclectic mix of high end restaurants and alfresco dining and lively bars and pubs. Boat Quay is arguably the favorite place to “chill out” for most professionals and expatriates. Lot of options available for drinks, dining from across the world. Most popular are the dining bars along the river. After a nice dinner one can head to one of the many pubs and discs around.
Sentosa is a popular island resort in Singapore, visited by some five million people a year. Attractions include a 2 km (1.2 mi) long sheltered beach, Fort Siloso, two golf courses, two five-star hotels, and the Resorts World Sentosa, featuring the theme park Universal Studios Singapore.