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Parenteral Drug Association Connecting People, Science and Regulation ®

2019 PDA Data Integrity Workshop

Sep 18 - Sep 19, 2019 |
Sep 19, 2019 |
Renaissance Washington, DC Downtown Hotel | Washington, DC
  • Conference
  • Western Hemisphere Events
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Data Integrity continues to be a major concern for Health Authorities and the pharmaceutical industry. Even though data integrity has been a requirement for years, recently there has been an increased focus on this topic both from a regulatory and industry perspective and Data Integrity has been the focus of numerous recent Health Authority enforcement actions such as Warning Letters, Import Alerts, product quarantines, and suspension or revocation of Marketing Authorizations. In addition, more guidelines and regulations have been published to establish Data Integrity Standards.

As Data Integrity programs mature, we need to transition from a reactive mode to a preventative mode and engrain Data Integrity into our Quality Management System and Culture. This conference will be comprised of interactive case studies, presentations, and roundtable discussions.

Learning Objectives

At the completion of this event, attendees will be able to:

  • Understand the current regulatory climate and remediation expectations and to define what is needed to engrain Data Integrity into the Quality Management System and Culture.
  • Promote a holistic understanding of the challenges faced by the industry in data integrity
  • Discuss strategies on how to utilize Quality Risk Management to prevent Data Integrity issues and establish a quality culture which promotes Data Integrity as a core value.

Who Should Attend

Job Functions
GxP Business Process and System Owners | Compliance professionals | Batch Release and Qualified Persons | Quality Risk Managers | Automation Leads | Auditors | Trainers | Quality Control Professionals | Regulatory and Compliance Counsel

Contacts

Brooke Schneider, CMP
Manager, Programs
(301) 656-5900 ext. 111
Email: schneider@pda.org

Registration & Customer Care
(301) 656-5900 ext. 115
Email: registration@pda.org

Exhibition inquiries
David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
Email: hall@pda.org

Workshop Registration | September 18-19

Member

By July 30, 2019
$1,495

After July 30, 2019
$1,695

Non-member

By July 30, 2019
$1,695

After July 30, 2019
$1,895


Young Professional Member †

Member

By July 30, 2019
$748

After July 30, 2019
$848

† You must be a member to take advantage of this rate.


Government/Health Authority/Academic

Member*

By July 30, 2019
$700

After July 30, 2019
$700

Non-member*

By July 30, 2019
$800

After July 30, 2019
$800

*For this member type or discounted rate, online registration is not available and must be faxed in.


Student

Member

By July 30, 2019
$280

After July 30, 2019
$280

Non-member*

By July 30, 2019
$310

After July 30, 2019
$310


All prices in US dollars.

*For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to take advantage of this rate.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund, and photo release policies for this workshop and course.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at registration@pda.org for help.

CONFIRMATION:A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by August 16, 2019 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee. If you are pre-registering as a substitute attendee,
indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). If your written request is received on or before August 16, 2019, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them.

CANCELLATION:PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be cancelled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: Tape recordings are prohibited at all PDA Events.

For more information on PDA's Privacy and Event Privacy Policies, please visit pda.org/privacy-policy and pda.org/event-privacy-notice.

More information coming soon. 

For more information about exhibit and sponsorship opportunities, please contact David Hall at +1 (301) 656-5900 ext. 160; cell +1 (240) 688-4405; hall@pda.org or Alison Caballero at +1 (301) 656-5900 ext. 135; caballero@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4763

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