Webinar Duration: 2 hours

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Laura Brown

Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This webx session will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

Why should you Attend: Data Integrity is now a focus for regulatory inspections, with both EU and FDA inspectors increasingly observing violations during GxP inspections. Data Integrity has become a critical issue in document governance and regulators expect staff working in GxP roles to have been trained in this important area.

Ensuring data integrity is an important component of the pharma industry’s responsibility to ensure the safety, efficacy, and quality of drugs. Data integrity-related violations have led to numerous regulatory actions, including warning letters and critical inspection findings. To address these concerns, the FDA, EMA, MHRA and the World Health Organization (WHO) have all recently published data integrity guidelines.

This concise webx session covers the background to data integrity, why it is important and how its requirements affect both paper-based and computer-based systems. The course will include discussion of the recently finalised MHRA data integrity guide which provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the GXP pharmaceutical lifecycle GCP, GMP, GLP and GvP. You will gain an understanding of the requirements for ensuring data integrity, review data integrity inspection findings, and practical advice in defining and implementing an appropriate data governance process for compliance with data integrity requirements.

Areas Covered in the Session:
– Understand the importance of data integrity
– Discuss data integrity criteria and definitions – eg ALCOA
– Be aware of key regulations and guidelines – MHRA / FDA/ EMA / PICS / ICH GCP R2
– Understand QMS considerations for data integrity
– Review data integrity inspection findings to check for compliance against data integrity expectations
– Consider the requirements for data integrity governance to prevent data integrity breaches

Who Will Benefit:
– Any GXP Role
– Clinical Research/GCP
– PV
– Regulatory Affairs
– Quality Assurance / Quality Control
– Legal and Compliance Office
– Compliance Manager
– Heads of Internal Audits
– Management
– CROs
– CMOs
– Clinical Trials
– QA Personnel

Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA. Dr. Brown has 20 years experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy.

She has worked for several international companies like GlaxoWellcome, Hoechst Marion Roussel and Phoenix International. Dr. Brown has published material on the new EU Clinical Trial Regulation and also a practical guide to the current regulatory requirements for carrying out clinical trials in the EU. She has penned a chapter on training QA staff in the leading GXP book “Good Clinical, Laboratory and Manufacturing Practices” (2007). She has authored SCRIP’s latest GCP guide and one entitled “Practical Guide to the Clinical Trial Directive”. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and in training courses on QA and GXP issues.

Dr. Brown  runs many training courses on topics such as: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, regulatory requirements for clinical trials, the clinical trial directive, managing clinical trials, QA management and business skills, how to prepare for audit and inspection, how to audit, etc.