Data Integrity, Fundamentals, Issues, Concerns, and Regulatory Requirements
Perspectives of Analytical Validation with Risk Based Strategy
On Dec. 6, 2016,
Chapman University,School of Pharmacy
Harry and Diane Rinker Health Science Campus
9501 Jeronimo Road, Room 203
Irvine, CA 92618-1908
Link to Google Maps for Chapman University, Health Science Campus:
8:00 am–9:00 am: Registration, Breakfast, and Networking
9:00am-9:45 am: A Comprehensive Introduction to Data Integrity
9:45 am–10:30 am: ALCOA+ and what constitutes Data Integrity Breaches
13:30 am – 10:45 am: Break and Networking
10:45 – 12:15: Perspectives of Analytical Validation with Risk Based Strategy
12:15 – 12:30 pm: Q&A and Close out.
There has been an outbreak of data integrity concerns from the USFDA, MHRA and other regulatory agencies in the past few years. Based on this Several documents have recently been published by the FDA, MHRA and WHO. The FDA Guidance for Industry, "Data Integrity and Compliance with CGMP" was published as a DRAFT guidance in April 2016. This Guidance was issued to clarify the role of Data Integrity in CGMP for drugs. In March 2015, the MHRA published a Guidance entitled "MHRA GMP Data Integrity Definitions and Guidance for Industry" which was innovative and became the basis for publishing other guidance in regulatory agencies. In this seminar we study the basis of data integrity problems, how they originate and how to detect and correct them. Various source documents to include 21 CFR 210/211, FDA Guidance for Industry, Standard Industry Practices and other International sources will be presented to support the content and conclusion of this seminar.
Additionally, highlights of Analytical Methods, their Development, Validation and Transfer to target laboratories will be discussed in the second part of the seminar. Major features of the more recent Guidance from FDA will be discussed vis-a vis the existing guidance from ICH, USP, WHO and EMA will also be discussed in this short presentation.
Who Will Benefit
• Those Persons who collect, analyze and report data.
• Pharmaceutical Quality Control and Quality Assurance Managers, Personnel, Researchers and Analysts.
• Laboratory personnel from R&D, Process Development, QC, QA, CRO, CMO and other technical organizations.
• Pharma and Biotech executives and Professionals including Scientists and Engineers.
• Professionals working in R&D, Manufacturing, Quality Assurance, Quality Control, Regularly Affairs and Finance
Abbass Kamalizad, Ph.D.
Dr. Kamalizad has taught and researched in analytical chemistry (gas and liquid chromatography, electrochemistry, spectroscopy) for over 14 years in universities and has over 20 years of experience in pharmaceutical industry, mostly related to drug development, quality control and quality assurance in a CGMP environment. Recently, as President of ACPC Group, he spent over 4 years in China and India with firsthand experience in international data integrity problems in the industry. He helped responding to regulatory warnings, removal from import embargo, getting prepared for regulatory audit and establishing quality system for API and drug product manufacturers to meet CGMP standards. India and China gave him international experiences necessary in helping companies in need of global quality compliance. He now continues providing consulting services for establishing total quality systems in compliance with CGMP rules and regulations as established by regulatory agencies such as USFDA, CFDA, EMA, TGA, WHO, and Health Canada and ICH, USP, EP, JP.
In the past he was in director positions with Anchen Pharmaceuticals, Irvine Analytical Laboratories (presently IPS), and AAI Pharma, overseeing laboratories operation in developing and validating analytical methods in support of product development and raw material, finished products and stability testing for commercial products as well as QC, R&D and Microbiology, IT, Business Development.
Abbass founded ACPC Group, a consulting firm for helping pharmaceutical industry to achieve fast success for application of products with FDA. Dr. Kamalizad holds a Ph.D. in Analytical Chemistry from University of Massachusetts, Amherst.
Shib Mookherjea, Ph. D.
Shib Mookherjea has a proven track record in analytical problem solving, R&D and extensive accomplishments in the areas of Pharmaceutical Development, (ICH Q6, Q7A, Q8), Management of QA/QC, Process Upgrade, CpK monitoring, PAT applications, Validation in the Laboratory (Methods, Systems, Equipment Qualification), and support for dosage forms, in process materials, excipients, DS, DP, medical devices, etc. He has held Management and supervisory positions within Pharma, Biotech and other companies including Colgate Palmolive, Johnson & Johnson, Troy Corporation, BASF & CRO/CMO Laboratories. Dr. Mookherjea is a highly-recognized speaker and is the Principal of VQI.
Time tested coordination and leadership ability paved ways to build and develop functional groups from the ground up, while ushering in systems, procedures, documentation and implementation of quality systems (GLP, cGMP, ISO 17025) and other international standards for regulatory compliance. Such challenges have been successfully met in various corporate settings by providing the needed training and guidance, utilizing the world-wide network of scientific professionals that remain an excellent source of reference and assistance in problem
Dr. Mookherjea provides global training and consulting in areas of Validation, Methods & Audits for GMP, GLP (FDA/OECD) ISO 17025, TQM, ISO 9000, Laboratory QA, and Accreditation. He is part of the continuing education faculty of the American Chemical Society, EAS, CFPA and other international training organizations.