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
USB with seminar presentation
Hard copy of presentation
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
Day 01(8:30 AM - 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • 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
    • Main reasons for non-compliance
    • Regulations and guidelines
    • 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
  • Module 3

    Strategies to detect and avoid integrity issues

    • Recruit, train and retain employees who will be responsible for ensuring data integrity
    • Preventing data integrity issues: Going through details of ALCOA+
    • Possible causes for data integrity breaches
    • Understand system vulnerabilities, motivation and likelihood operators might compromise data
    • Understand the company’s quality culture
    • Understand high risks in the data lifecycle
    • Learning from internal audits and FDA inspections
  • Module 4

    The Quality System as Prerequisite for Data Integrity

    • Contributing factors to poor quality
    • Consequences of poor quality systems
    • Recommendations from the FDA
    • Developing a Quality Culture
    • ICH Q10 – The quality system for pharma industry
    • Implementing key requirements: e.g., CAPA system, failure investigations,, training, audits
    • Assessment of data integrity risks
    • Steps for on-going improvement
Day 02(8:30 AM - 4:30 PM)
  • Day 2 - Lectures and Workshop Exercises
  • Module 5

    Cost effective Validation of software and computer systems

    • Selecting the right validation lifecycle model
    • Going through examples of a complete computer system validation from beginning to end
    • How risk assessments can help to determine the type and extent of validation
    • Defining user requirements based on risk
    • Vendor assessment and supplier agreements
    • Testing and documenting installation
    • Going through examples for OQ and PQ testing
    • Maintaining the validated state
  • Module 6

    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 7

    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
    • Examples
  • Module 8

    Data Integrity Auditing: Internal 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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Dr. Ludwig Huber

Dr. Ludwig Huber
Director and Chief Editor, LabCompliance

Dr. Ludwig Huber is Director and Chief Editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories . Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences.

He served as a team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on laboratory equipment. In addition, he was awarded as Presenter of the Year of the Institute for Validation and Technology. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press.

For more information, visit www.ludwig-huber.com

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Register Now

Online using Credit card

$1,499.00

Seminar One Registration

February 13-14, 2017, San Francisco, CA
(For Registrations till January 5, 2017 - $1499)
(For Registrations till January 25, 2017 - $1699)
(For Registrations after January 25, 2017 - $1899)

$2,599.00

Seminar One Registration (With 2 Nights Stay)

February 13-14, 2017, San Francisco, CA

$6,799.00
$8,994.00 (24%)*

Save $2,195.00

Special Group Discount Register for Six attendees

February 13-14, 2017, San Francisco, CA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

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ComplianceOnline (MetricStream, Inc),
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Palo Alto, CA 94303
USA

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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

Hilton San Francisco Airport Bayfront
600 Airport Blvd,
Burlingame, California, 94010, United States
Tel:650-340-8500

February 13-14, 2017

How to Reach

General Driving Directions:

Driving directions from San Francisco International Airport – 4 miles:
  • Exit airport 101 South towards San Jose.
  • Take Broadway/Burlingame exit.
  • Take 2nd right to overpass to other side of freeway. 1st light, turn right.
  • Next light turn left onto Airport Blvd. Hotel is located in 1 mile.
Driving directions from San Jose International Airport – 32 miles:
  • Start out going Southeast on Airport Blvd.
  • Turn slight Left to CA-87/ Skyport Dr.
  • Merge onto CA -87 N. via the ramp to US-101 N.
  • Take US-101 N. Take Anza exit and turn right on Airport Blvd. Hotel is on the left.
Driving directions from Metropolitan Oakland International – 32 miles:
  • Exit airport and turn left onto Davis/CA-61.
  • Merge onto I-880 toward San Jose.
  • Take exit 27 toward CA-92 toward San Mateo/Half Moon Bay.
  • Cross the bridge and merge onto US-101 N. Exit Peninsula Ave, exit 417B. Left on Airport to the hotel.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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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
Platinum Partner
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  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • 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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