ComplianceOnline

Course "Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2015/2016)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore with a greater frequency than usually observed within the United States. A lack of Data Integrity hints of a Company being outside of compliance and questions the quality of the product being produced.

Often the initial "hint" of an off-shore problem occurs within FDA "circles" when one first observes an "Import Alert". These Import Alerts don't offer much information other than the country, the Company and the product. However, this becomes a tell-tale signal that a Warning Letter will most likely be issuing within three to four months.

Data Integrity issues may represent very simplistic issues that any auditor may readily observe to those that are so complex that only someone very skilled in the art of auditing can readily find them. During this two day seminar various examples of Data Integrity issues will be reviewed to include how and where to locate them during audits. In addition, breakout sessions will be held to learn from each other and other teams as they review the same data and compare their findings. Interestingly, conclusions developed by the various teams often differ from each other.

Several documents have recently been published by the FDA, MHRA and WHO. The FDA Guidance for Industry, "Data Integrity and Compliance with CGMP" was published as a DRAFT guidance in April 2016. This Guidance was issued to clarify the role of Data Integrity in CGMP for drugs. In March 2015, the MHRA published a Guidance entitled "MHRA GMP Data Integrity Definitions and Guidance for Industry" which mirrored the 2016 FDA document. Various source documents to include 21 CFR 210/211, FDA Guidances for Industry, Standard Industry Practices and other International sources will be used to support the conclusions developed by each team during this two day seminar.

The objective of this two day Compliance On-Line seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program and how to maintain Quality Systems that minimize these issues. This seminar is designed to assist in assuring that your organization is maintaining itself within cGMP compliance. Case studies to include Warning Letters will be discussed to illustrate the wide array of issues that continue to arise and how to find them within your organization and your vendors before the regulators find them for you. This seminar represents a great opportunity for a team from your Corporation to attend and mutually benefit each other.

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:

Upon completing this course participants should:

  • Assure your understanding of the fundamental causes of Data Integrity issues
  • Be able to identify these key elements
  • Understand how cGMP regulations impact Data Integrity issues
  • Understanding the various inspection approaches to monitor for Data Integrity
  • Learn how to determine the regulatory requirements required to assure Data Integrity
  • Understand the consequences of questionable data and how they may lead to seizures, import alerts, etc

Who Will Benefit:

Those that will benefit from this program include anyone involved in the incoming materials, manufacturing, laboratory and packaging process within a non-sterile/aseptic pharmaceutical environment.

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality Control
  • Microbiology
  • Document control specialists
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 08.00 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
    • Overview of Data Integrity – The issues
      • Background
      • Purpose/Objective
    • Definitions
      • Key definitions within the subject of Data Integrity
        • Data Integrity
        • Metadata
        • Audit Trail
        • Systems
    • Determination of the Key Regulatory Requirements to maintain Data Integrity
      • GMP requirements of Data Integrity
      • 21 CFR 210, 211, and 212 – an explanation of the most common CFR sections
    • The Most Prevalent 2015 Observations Associated with Data Integrity
      • A Review of Nineteen Observations
      • Why do they Repeat Year after Year
    • A Summary of Data Integrity Issues within:
      • In-coming Materials
      • Manufacturing
      • Laboratory
      • Training
      • Finished Products
      • Documentation
      • Product Release
Day 02(8:30 AM - 4:30 PM)
    • Key Issues Associated with Data Integrity to include:
      • Exclusion of Data from Decision Making
      • Validation of Workflow
      • Restriction to Computer System Access
      • Data Integrity Remediation
      • And Many more
    • Breakout for Case Studies
    • Discussion of Case Studies to include recommendations
    • The breathe of falsification to include laboratory, stability, microbial and batch testing – where did they go wrong?
      • Hemofarm - Serbia – Microbiological Issues
      • Unimark – Basic issues with Data Integrity
      • Megafine Pharma Limited – Liquid Chromatography
      • Micro Labs LTD – Laboratory Records
    • Why Import Alerts may share Early Warning Issues
    • Why do fraudulent records continue to appear – despite a history of Warning Letters
    • Avoiding Responsibility through Contract Manufacturing and Testing Facilities – Does this work?
    • Case Studies and recent Warning Letters
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Barry A. Friedman

Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.

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Register Now

Online using Credit card

$1,899.00

Seminar One Registration

December 8-9, 2016, Orlando, FL

$2,099.00

Seminar One Registration (With 2 Nights Stay)

December 8-9, 2016, Orlando, FL

$8,799.00
$11,394.00 (22%)*

Save $2,595.00

Special Group Discount Register for Six attendees

December 8-9, 2016, Orlando, FL
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




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

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

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.

Online using Credit card

$1,899.00

Seminar One Registration

May 18-19, 2017, Boston, MA




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

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

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.

1

Orlando, FL
December 8-9, 2016

Hotel

Renaissance Orlando Airport Hotel
5445 Forbes Place,
Orlando, FL 32812, USA

Tel:+1 407-240-1000 & (407) 513-7207.

Special Offer

Special Offer for the attendees of this seminar

Rooms available at only $202 per night.

Please note: Hotel rooms are limited and based on availability.

How to Reach

General Driving Directions:

Driving directions from Orlando International Airport – MCO: 1 mile
  • Take the north exit from the airport (436).
  • Proceed to the first traffic light and turn left onto the frontage road.
  • Take the first entrance on the right (Forbes Place).

Other Transportation:

Bus Station
  • Greyhound 12.8 miles NW
Train Station
  • Amtrak 10 miles NW

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.

2

Boston, MA
May 18-19, 2017

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  • Logo placement on the podium
  • Logo on the lanyards for all speakers
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  • A full page brochure advert
  • Moving banner ad on the website
Gold Partner
  • Logo on promotional email campaign
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  • A half page brochure advert
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  • Moving banner ad on the website
Silver 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
  • 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

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
  • 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
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 Orlando, FL

Walt Disney World Resort

Walt Disney World Resort

This massive, world-famous theme park includes Magic Kingdom Park, Disney - MGM Studios, Epcot, Disney's Animal Kingdom, Downtown Disney, and more.

Magic Kingdom Park

Magic Kingdom Park

Opened in October of 1971. One of the most famous theme parks in the world featuring Cinderella's castle with classic rides like Pirates of the Caribbean, Haunted Mansion, Space Mountain, Country Bear Jamboree, Hall of Presidents, etc. Frontierland, Tomorrowland, Liberty Square, Adventureland, and Fantasyland, Great for families with kids 10 and younger.

Universal Studios Orlando

Universal Studios Orlando

Theme studios park features Jaws, T2, Twister, Men In Black, etc. and various back lot sets used in the movies. CityWalk is an entertainment venue with many restaurants, night clubs, retails stores and a great party atmosphere. Movie theatre near the entrance. Also Hard Rock Cafe, Jimmy Buffet's Margaritaville, Emiril's, NASCAR Cafe.

Wet 'n Wild

Wet 'n Wild

Have a splashing good time at one of the country's premier water parks, offering rides for all ages.

Pointe Orlando

Pointe Orlando

Featuring open-air shopping, dining and entertainment, with more than 40 specialty retailers, delicious restaurants, and exciting entertainment.

Local Attractions of Boston, MA

Boston Public Garden

Boston Public Garden

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

Boston Public Library

Boston Public Library

The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).

Fenway Park

Fenway Park

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

Museum of Fine Arts

Museum of Fine Arts

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

Museum of Science

Museum of Science

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

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