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Seminar Price Details

Seminar Fee for One Delegate
Price : US$700.00

Register for 5 attendees
Price : US$3,500.00

Register for 10 attendees
Price : US$7,000.00

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
  • Venue


This course is designed for people who are growing in their knowledge of pharmaceutical manufacturing. It will be a “how to” course where the instructor will explain the reasoning as well as the procedures that should be used to ensure data integrity. The instructor will present different areas for consideration and present them with a practical approach so that the participant can see how the subject matter applies to the participant’s work either now or in the future.

In addition to discussing the particular subjects the instructor will explain how pharmaceutical regulatory requirements are met through the use of proper methods for assuring data integrity. The instructor has decades of experience in working with and within the regulated pharmaceutical industry in the U.S. He has also acted as an international auditor and consultant, having worked in many countries and regions of the world. He will be covering topics that he is familiar with and will present them in a manner aimed at workers who may have little or no training related to data integrity, but now wish to raise their level of understanding. 

Why you should attend

The supervisors and workers who manufacture and assess the quality of pharmaceutical products are primarily responsible for assuring that the data they generate is accurate and reliable. This is not attained simply by having a few work procedures and rules, but also by having a culture of integrity among the responsible individuals. This seminar will provide the participant with the tools for ensuring the reliability of data, and also with ideas relating to the philosophical need for the integrity of the data.


Day 1 Schedule

Lecture 1: Basic Regulatory Requirements for Data

  • General need for honest data
    • Ethical requirements in the pharmaceutical industry
  • Global Regulatory Agencies and Their Interactions
    • Guidance documents and critical phrases
  • The U.S. GLP
  • The U.S. GMP

Lecture 2: Personnel Training

  • Selection of workers
    • Look for honesty
  • The need to explain things to workers and the consequences of non-compliance
  • Work procedures
    • Checking laboratory notebooks and instrument output
    • Verify audit trails and instrument data

Lecture 3: Statistical Considerations for Reliable Data

  • Averages and standard deviations
  • Sampling and replicate problems
    • General sampling rules
  • Arithmetic fallacies

Lecture 4: The FDA and MHRA Guidance Documents

  • The FDA Guidance Document
    • Critical definitions and expectation
    • Interaction with the computer validation regulations
    • Existing GMP regulations that are being applied to the subject
  • The MHRA Guidance Document
    • Differences between the MHRA and FDA documents

Day 2 Schedule

Lecture 5: The PIC/S Guidance Document Part 1

  • Data Governance and Risk Management
  • Code of ethics and policies
  • Data Integrity principles and enablers
  • Internal data integrity issues

Lecture 6: The PIC/S Guidance Document Part 2

  • Data Integrity for paper-based systems
  • Control of blank forms and templates
  • Records and true copies
  • Data Integrity for computerised systems

Lecture 7: Accessing and Reviewing Electronic Audit Trails

  • How to access audit trails
  • Reading and interpreting audit trails
  • Audit trails in various instruments

Lecture 8: Lessons from FDA Warning Letters

  • The speaker will illustrate data integrity issues, using citations from U.S. FDA Warning Letters that were sent to various companies
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Steven S. Kuwahara

Founder & Principal,

Steven S. Kuwahara , Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.


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