Key Points of Global Quality Assurance System and Safety Assurance in GMP for Investigational Drugs
★A thorough explanation from the basics to global compliance measures for clinical trial drug GMP, taking into account audit experience! ★Introducing many actual concrete examples, including responses to QP!
【Instructor】QA Advisor, Doctor of Medicine, Akira Nomura 【Venue】Kawasaki City Educational and Cultural Center, Room 1 【Kanagawa, Kawasaki】10 minutes on foot from JR and Keikyu "Kawasaki Station," 12 minutes from JR Shinagawa Station to Kawasaki Station 【Date and Time】January 26, 2011 (Wednesday) 13:00-16:30 【Capacity】30 people 【Attendance Fee】45,150 yen per person (including tax and text costs)
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basic information
【Course Objectives and Aims】 The instructor will give a lecture on the global compliance of GMP for investigational drugs, based on their auditing experience, starting from the basics. Points to consider in cases of outsourcing and contracting, management of overseas manufacturing sites, and other related topics will also be discussed. The management of documentation will be addressed from the basics of creation. Many practical examples, including responses to QPs, will be introduced throughout the presentation. It would be greatly appreciated if this could be utilized to improve compliance with GMP for investigational drugs.
Price information
New members who apply for the first time by January 17 will receive an early bird discount price of 39,900 yen. If two people apply from the same corporation, the price is 69,300 yen.
Price range
P2
Delivery Time
P2
Applications/Examples of results
1. Legal Positioning of Clinical Trial Drug GMP 2. Implementation and Verification of Clinical Trial Drug GMP 2-1 Purpose of Clinical Trial Drug GMP - Quality Assurance and Safety Assurance - Q1 What are the risk management and countermeasures when administering to humans for the first time? Q2 What does ensuring the safety of subjects entail? How does it relate to GLP, GCP, Clinical Trial Drug GMP, and reliability standards? 2-2 Clinical Trial Drug GMP Software - Manufacturing System, Organization, Standard Operating Procedures - Q1 What are the basics of organizational structure? Q2 What does the preparation of documents (standard operating procedures for clinical trial drug products, specifications, standard operating procedures) involve? Q3 What is raw material management? Q4 What is manufacturing management? Q5 What are change management and deviation management? Q6 What does the handling of quality information/quality defects and recall processing involve? 2-3 Hard Aspects of Clinical Trial Drug GMP - Facilities and Equipment - Q1 What is the design of equipment and facility layout? 2-4 Points to Consider in Record Document Management Q1 What does document creation, management, and storage involve? Q2 What are the document management systems and standards? Q3 What are the considerations for validation? 3. Establishment of Pharmaceutical Quality Assurance System and Crisis Management Q1 What is the role of internal audits? Q2 What are the responsibilities of each department? Q3 What are the basic responses to investigations from authorities and partner companies? 【Q&A】
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