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Short Course

Course Information
Course Title: Data Integrity: Practical Steps to Identify and Avoid Data Integrity Issues in the Pharmaceutical Laboratory
Categories: 1 - Pharmaceutical Sciences
2 - Quality/Regulatory/Compliance
Instructor(s): Greg Martin Course Number: 117
Affiliation: Complectors Consulting
Course Date: 03/05/2017 - Sunday Course Length: 1/2 Day Course
Start Time: 08:30 AM End Time: 12:30 PM
Fee: $325 ($425 after 2/18/17) Textbook Fee:

Course Description
Data integrity is fundamental in a Pharmaceutical Quality System which ensures that medicines are of the required quality. This requires an understanding the expectations for data integrity from a CGMP perspective. Reviewing FDA guidance documents and citations in FDA Warning Letters will facilitate this understanding. Providing practical steps which can be taken will help your organization reduce the likelihood of receiving a Warning Letter due to Data Integrity issues Upon completion of this course the learner should: 1. Understand what Data Integrity is, and why it is so important. 2. Be familiar with regulatory expectations for laboratory notebooks and computer systems. 3. Be familiar with issues that resulted in Warning Letters from the FDA. 4. Understand some practical steps that can be taken to facilitate good documentation and reduce the likelihood of receiving a Warning Letter for Data Integrity issues.

Target Audience
Chemists, Supervisors and Managers in Pharmaceutical Laboratories (Innovator and Generic companies for Human and Animal products, and associated Contract organizations), including Quality Control and Research, responsible for developing or implementing dissolution methods, and Quality Assurance or Regulatory Affairs Personnel.

Course Outline
• What is meant by ‘Data Integrity’?
• Data Integrity expectations from the FDA Guidance
• Discussion on computer systems, notebooks and spreadsheets
• FDA Warning Letters citing Data Integrity Issues
• Practical steps you can take to avoid being cited
• Questions and discussion

Course Instructor's Biography
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation, and is past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group. He can be contacted at greg.martin@complectors.com.