PharScite in Conjunction with CfPA Presents:
ICH Q10: Pharmaceutical Quality System

December 17-18, 2020; Ho Chi Minh City, Vietnam

The draft of ICH Q10 is the latest document that aims to define the requirements for a quality system for pharmaceutical operations. It discusses how the function of the system should evolve during pre-market operations, what its function is when a drug is marketed and how opportunities for product improvement should be identified and implemented throughout the product life cycle. The main element discussed in Q10 is what management, especially senior management should be responsible for in assuring an effective Quality System. Other important elements receiving an emphasis in Q10 are the Quality System components such as change control, deviation control, CAPA, root cause determination, input/process/output monitoring, product reviews and documentation. This course analyzes the content of Q10 and compares it with previous standards including the FDA Guidance on Quality Systems and ISO 9000. It analyzes its relationship with Q8 (Product Development) and Q9 (Risk Management) and the FDA Guidance on their Six-Systems Inspection Program and discusses the quality systems to which Q10 refers with particular reference as to how such systems can be effectively managed & integrated in accordance with Q10. Throughout the course interactive discussion on this new, most important and far reaching Guideline will be encouraged.

Who Should Attend

This course has been designed to benefit those in the Pharmaceutical industry with responsibilities related to the design, operation or management of the overall Quality System or any individual quality system used by the industry. The course is particularly suitable for personnel working in:

Site & Corporate Management
Regulatory Affairs
Pre-Market Departments
Quality Units (including QA, QC & Quality Audit)

The course is applicable to personnel in API, commodity and outsource suppliers to the industry in addition to those in primary

Learning Objectives

Upon completion of this course, you will be able to:

Define the requirements of ICH Q10
Compare the relationship of ICH Q10 with other standards including ISO 9000 & the FDA Guidance on Quality Systems
Identify how ICH Q10 relates to ICH Q8 (Product Development) and ICH Q9 (Risk Management)
Evaluate the roles that employees at different levels, including Senior Management, are required to play in the management of quality
Identify how the functions of the Quality System and its component systems can be effectively & efficiently integrated

Course Director

Dr. Alan J. Smith is a consultant specializing in pharmaceutical quality & technology. He was formerly the Corporate Director of Quality Affairs for the Whitehall Laboratories Division of American Home Products Corporation (now Wyeth) following an extensive career with the Ayerst Division. Dr. Smith received his B.Sc. & Ph.D degrees in Chemistry from the University of London and also studied Business Administration at the Wharton School of the University of Pennsylvania. He has had experience in both the chemical & pharmaceutical industries in research, analytical methods development, stability programming, regulatory affairs, quality control & corporate quality assurance. He is a member of the American Chemical Society & the American Society for Quality, and has been Chairman of numerous pharmaceutical conferences and a member of several industrial association committees including the PMA (now PhRMA) Committee on Stability & Expiration Dating & the ASTM Committee on Quality Systems. Dr. Smith is a member of the Editorial Advisory Boards of Pharmaceutical Technology and Journal of GXP Compliance.

He was also the recipient of the 1998 WorldPharm award for Service to the Pharmaceutical Industry. Dr. Smith’s consulting has included work with firms under consent decree. He served as a member of the Board of Directors of Halsey Pharmaceuticals 1996-2004.

Accreditations/Recertifications For This Course

The Center for Professional Advancement (CfPA) has been approved as an Accredited Provider by the International Association for Continuing Education and Training (IACET), 11130 Sunrise Valley Drive, Suite 350, Reston, VA 20190. In obtaining this approval, CfPA has demonstrated that it complies with the ANSI/IACET Standards which are widely recognized as standards of good practice internationally. CfPA is therefore authorized to offer IACET CEUs for its programs that qualify under the ANSI/IACET Standards. CEUs will be awarded for participation in CfPA’s courses at the rate of .1 CEU per contact hour upon successful completion of the entire course and 70% accuracy in the required Learners’ Assessment. This course offers a total of 12 contact hours, or 1.2 CEUs.