Bethesda, Md., March 11, 2016 – The Parenteral Drug Association (PDA) is rolling out resources for pharmaceutical companies to use for strengthening the integrity of their manufacturing and quality data as part of a comprehensive effort to assist the industry with this sensitive and important area. These work products will be catalogued on a new PDA Data Integrity web page at: www.pda.org/dataintegrity.
A data integrity program is a significant component of a company's Quality System, providing foundational assurance that the data used to demonstrate a company's products are safe and effective for their intended use. Data integrity is a major concern of Health Authorities worldwide. Although not a new issue, numerous recent Health Authority enforcement actions have focused attention on data integrity.
PDA is developing a comprehensive set of tools for industry that includes a recently published “Code of Conduct,” a series of workshops, a book with practical advice on how to prevent or rectify data integrity breaches and technical reports. As each new tool is available, it will be posted to the newly launched Data Integrity web page.
2016 PDA Data Integrity Workshops
These workshops will include a blend of presentations from regulatory and industry experts, case studies and round table discussions. The schedule of workshops:
“Code of Conduct for Data Integrity”
The Elements of a Code of Conduct for Data Integrity was developed by a team with expertise in the fields of quality, regulatory affairs, auditing and manufacturing and reviewed by attorneys specializing in food, drug and labor law. It is written for easy adoption by companies without the need for extensive rewriting of the document. It is available for free at: www.pda.org/codeofconduct.