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Event NameSan Diego - 2016 PDA Data Integrity Workshop
Event Date(s) Wednesday, December 07, 2016  to Friday, December 09, 2016
Event Location Manchester Grand Hyatt San Diego
San Diego , California
Cost$280 - $2,154
DescriptionData integrity has been and currently is a major global concern of Health Authorities and the pharmaceutical industry. Although not a new issue, numerous recent Health Authority enforcement actions (e.g., Warning Letters, Product Detentions) have brought increased attention to this subject.

Data integrity can result from lack of awareness, employee errors, failure to check accuracy of data, software or system malfunction, configuration problems with electronic data handling, or misconduct by employees. The challenges in the area of data integrity include but are not limited to, the increased reliance on electronic systems and complexity of supply chains. Companies must put in place a holistic, multi-faceted approach to address the underlying causes leading to data integrity risks and issues. To holistically address data integrity, PDA has planned a number of activities, including the 2016 Data Integrity Workshops, technical reports, Education courses, and the Elements of a Code of Conduct for Data Integrity, written for easy adoption by companies in the industry to address this serious issue.

The 2016 PDA Data Integrity Workshops will include a blend of presentations from regulatory and industry experts, case studies and round table discussions. Special focus on exploring the multiple facets of data integrity, such as quality culture, human behavior, training needs, and technology requirements, will help attendees get a broad perspective on common factors, and cause and effect. Through round table discussions, attendees will learn about best practices for preventing, detecting, mitigating and remediating data integrity issues. Ample opportunity will be provided for attendees to network with industry peers, regulators and solution providers to enhance the overall learning experience.

Learning Objectives

The main focus and aim of this Workshop is to understand the multiple facets of data integrity such as quality culture, human behavior, training needs, and technology requirements. In addition to promoting a holistic understanding of the challenges faced by the industry in this area, this event, will discuss strategies on how to tackle these (prevention, detection, response and learning). The the two-day Workshop agenda is comprised of interactive case studies, presentations and round table discussions.

Who Should Attend

• GxP Business Process and System Owners

• E-Compliance professionals

• Batch Release and Qualified Persons

• Quality Risk Managers

• Automation Leads

• Auditors

• Quality Control professionals

• Regulatory & Compliance Counsel
Host CompanyParenteral Drug Association
Contact Information Phone: +1-301-656-5900 ext. 132
Fax:   N/A 
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