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2020DataIntegrity-1988x680

2020 PDA Data Integrity Webinar Series

Sep 02 - Sep 10, 2020
, Online

Data Governance Programs: Fit for Innovation

  • Virtual
  • Workshop
  • Conference
  • Online
  • The Americas
Program Highlights

The 2020 PDA Data Integrity Workshop is going Virtual! Join us for this four-part Webinar Series on Sept. 2, Sept. 3, Sep. 9, and Sept. 10. Registration will be opening soon!

Overview

Data Integrity continues to be a major concern for Health Authorities and the pharmaceutical industry. Even though data integrity is a foundational requirement of all GXP regulations, there continues to be an increased focus on this topic both from a regulatory and industry perspective as data integrity breaches still drive a significant number of Health Authority enforcement actions such as Warning Letters, Import Alerts, product quarantines, and suspension or revocation of Marketing Authorizations.  Moreover, additional guidelines and regulations have been published to establish Data Integrity Standards.

As data integrity programs mature, firms will need to consider transitioning from a reactive model (assessments) to a preventative model and engrain data integrity into their Quality Management Systems and Culture, potentially modernizing historical control strategies to address current controls and risk scenarios. This will lead to exciting new opportunities for people, process, products, and technologies to emerge through the introduction of Data Governance, Data Process Design, Data Analytics, and Big Data initiatives—all with an intent to optimize the availability, usability, and reliability of data to enhance Management Review and  Knowledge Management Programs.  This transformation journey will demand modern, agile, flexible, and scalable Quality Risk Management strategies and inspired Cultural Change Management.

Agenda Coming Soon

Additional Information

  • Learning Objectives

    Learning Objectives

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

    1. Understand the current regulatory climate and remediation expectations and to define what is needed to ingrain Data Integrity into the Quality Management System and Culture.
    2. Promote a holistic understanding of the challenges faced by the industry in data integrity.
    3. 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

    Who Should Attend

    • GxP Business Process and System Owners
    • Compliance professionals
    • Batch Release and Qualified Persons
    • Quality Risk Managers
    • Automation Leads
    • Auditors
    • Trainers
    • Quality Control professionals
    • Regulatory & Compliance Counsel
    • Data scientists

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.


, Online

 
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  • Amenities
     

How to Get Here

By Air

More information coming soon.

By Car

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Other Options

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Directions

Registration Fees

Early Registration
 
Regular Registration
 

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

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

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

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Aug 14, 2020, no fee will be charged. After Aug 14, 2020, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Aug 14, 2020, a full refund will be given minus a $200 fee. After Aug 14, 2020, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900 ext. 115
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