PharScite in Conjunction with CfPA Presents:
Surviving an FDA Inspection: FDA Inspection of Non-U.S. Sites
June 18-19, 2020 | Kuala Lumpur, Malaysia
This course provides an overview of the FDA inspection process in general and of particulars applicable to “foreign inspections”. It provides a background and understanding of the role played by the Agency, its administrative and enforcement powers. The course provides a step by step description of the inspectional process with specific examples regarding cGMP compliance inspections and pre-approval inspections. The FDA initiatives regarding inspections, like risk based approach and system based approach, will be discussed in detail. This will enable participants to better understand how to prepare their companies for FDA inspections. The course consists of lectures, discussions, and hands-on case studies.
Who Should Attend
This overview course is intended for individuals whose functions have direct or indirect involvement with FDA inspections. These functions include among others:
• Top Management
• Quality Assurance/Control
• Regulatory Affairs
• Research & Development
• Quality Systems Management
• Documentation Management
The course will focus on various types of inspections in the pharmaceutical, medical device and related industries and will look at policies, procedures and experiences relevant to those inspections.
Upon completion of this course, you will be able to:
• Discuss the organization, structure and role of the FDA
• Outline the rationale for and the process of foreign inspections
• Identify what the inspectors are looking for, how they perform cGMP compliance inspections as well as pre-approval inspections, and what kind of consequences can be expected as a result of non-compliance
Kimberly Johnson, is an industry veteran and specializes in the areas of Quality Assurance and Quality Management Systems. Prior to consulting, Ms. Johnson has been in the industry 25+ years serving in numerous quality management roles with start ups to Fortune 500 companies (DepoTech, Bristol Myers Squibb, Wyeth, Purdue Pharma, Watson Laboratories, Inc., Pii and Cambrex) managing combination products, medical devices, parenterals and pharmaceuticals (solid and liquid oral, topical and transdermal).
Ms. Johnson is skilled in the development, implementation, maintenance and continuous improvement of Quality Management Systems that include Audits & Inspections, Document Management, Change Management, Risk Management, Corrective and Preventive Action and Effectiveness programs, Deviations and Investigations, Complaint and MDR Handling, Supplier Qualification, Data Integrity and Quality System Management Metrics and Trending.
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.