Follow us:

Data integrity issues continue to pose a significant global problem, and regulatory agencies around the world have responded with additional guidance and stronger enforcement.

Protect your company against warning letters and product detentions! Gain a comprehensive understanding of current regulatory expectations by attending the 2016 PDA Data Integrity Workshop, held in San Diego, CA on Dec. 7-8. The final installment of this popular Workshop (the Washington, DC Workshop in September was oversold!) will combine presentations from industry and regulatory experts, case studies and breakout working groups/discussions to explain the factors that contribute to data integrity issues and help industry professionals take a holistic view of data integrity.

Gain practical solutions to real-world data integrity problems, such as:

• Analytics and Quality Control: A case study will illustrate the potential implications of data integrity violations at a clinical study site and showcase appropriate actions to determine the root cause and prevent future errors.
• Manufacturing: An example of a data integrity incident in a manufacturing setting will highlight the impact that culture and leadership have on data integrity.
• Quality Culture and Assuring Integrity of Data in a Global Environment: Cultural aspects that influence data integrity and management’s obligation to establish effective systems and processes to ensure accuracy and reliability of data will be discussed in depth.

Be sure your company stays compliant by avoiding data integrity issues! Register today.

Immediately following the Workshop in San Diego, PDA Education will hold the 2016 Data Integrity Workshop Course Series on Dec. 9. Investigating Microbial Data Deviations will explore the regulatory and scientific elements that must be considered when investigating microbiological data deviations. CMC Regulatory Requirements in Drug Applications will present basic CMC requirements for drug applications and supplements.