ComplianceOnline

There is no doubt that data integrity is the current and future inspection focus of all regulatory health 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.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Sessions indicated with (*) include one or more workshop exercises

Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Day 1 – Lectures and Workshop Exercises
  • Module 1: 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
  • Module 2: 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
  • Module 3: 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
  • Module 4: 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 02(8:30 AM - 4:30 PM)
  • Day 2 - Lectures and Workshop Exercises
  • Module 5: 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
  • Module 6: 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
  • Module 7: 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
  • Module 8: 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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Dr. Ludwig Huber

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 phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,599.00

Seminar One Registration (USD)

March 21-22, 2017, Hong Kong
(For Registrations till December 20, 2017 - $1599)
(For Registrations till January 15, 2017 - $1799)
(For Registrations till February 20, 2017 - $1899)
(For Registrations after February 20, 2017 - $1999)

$2,199.00

Seminar One Registration (USD) (With 2 Nights Stay)

March 21-22, 2017, Hong Kong

$7,399.00
$9,594.00 (22%)*

Save $2,195.00

Special Group Discount Register for Six attendees (USD)

March 21-22, 2017, Hong Kong
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Great Saving with Group Ticket!!! Only 3 left




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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 @ customercare@complianceonline.com

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 $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.

Location

Hong Kong
(Venue to be announced shortly)

March 21-22, 2017

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If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

Sponsors
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  • Exclusive stall at the entrance
  • A full page brochure advert
Gold Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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Local Attractions of Hong Kong

Ocean Park Hong Kong

Ocean Park Hong Kong

Ocean Park Hong Kong is a theme park that provides fun for all the family, from tropical rainforests to polar expeditions, and educational exhibits to thrilling roller. With an area of 170 acres, it's one of the largest ocean parks in the world.

Hong Kong Disneyland

Hong Kong Disneyland

Hong Kong Disneyland is a must-see because of its special attractions and the inimitable sense of Chinese culture. The park consists of seven themed areas: Main Street, U.S.A., Fantasyland, Adventureland, Tomorrowland, Grizzly Gulch, Mystic Point, and Toy Story Land.

Hong Kong Ladies Market

Hong Kong Ladies Market

With over 100 stalls of bargain clothing, accessories and souvenirs, the Ladies’ Market on Tung Choi Street provides a one-kilometer stretch on which to practice your haggling skills.

Victoria Peak

Victoria Peak

Victoria Peak is a mountain in the western half of Hong Kong Island. It is also known as Mount Austin, and locally as The Peak. The Peak, Hong Kong's most popular attraction is more than just stunning vistas or great shopping and dining. It's an amazing collection of unique must-visit attractions, providing you with a diverse fun-filled experience of Hong Kong's living culture.

Lantau Island

Lantau Island

Lantau Island is the largest island in Hong Kong, located at the mouth of the Pearl River. Buddhist architecture; fireworks over Sleeping Beauty's castle; a long sandy beach; a mall of shopping outlets – Lantau Island has it all. Whatever your persuasion, Hong Kong’s largest outlying island brings solace to the soul, senses and shopping bags.

Hong Kong Convention

Hong Kong Convention and Exhibition Centre

With its vast curtain of glass and 40,000 square-meter aluminum roof sculpted to echo a seabird soaring in flight, the striking Hong Kong Convention and Exhibition Centre is a major landmark on the Hong Kong Island skyline. Known worldwide as HKCEC, this harbour-front expansion used top-down construction techniques to meet a challenge of limited land supply; its highly innovative methods winning many industry accolades.

Bank of China Tower

Bank of China Tower

The prism-like façade of the 367.4m Bank of China Tower has become one of Hong Kong skyline’s most recognisable and appreciated features. The work of renowned Chinese–American architect I.M. Pei, the 70-storey building's asymmetrical form is pure geometry and has been compared to a bamboo plant, which extends its trunk successively higher with each new burst of growth.

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