How to Effectively Conduct GCP Audit and Inspections February 27-28, 2014 Beijing, China This two-day course provides an in-depth, practical, and interactive forum so participants can better understand the critical aspects of GCP and, especially, how to detect deviations from GCP and regulations, how to prepare for a regulatory inspection and a sponsor or independent audit, what tools are available to conduct an assessment or investigation when such deviations have been observed and how to conduct an effective CAPA (Corrective Actions and Preventive Actions) program following an inspection or audit, or upon the detection of deficiencies or breaches. The course will be supported with real-life examples and will deliver a comprehensive understanding of internationally accepted and required principles of the management of deviations from GCP and regulatory requirements. WHO SHOULD ATTEND XX Clinical Study Directors XX Clinical Trials Managers XX Clinical Trial Monitors XX Study Coordinators XX Study Project Managers XX Quality Assurance Staff and Auditors XX Pharmacovigilance Compliance Staff FEATURED TOPICS XX New Trend & Hot Topics for Global GCP Compliance Regulations XX China GCP Compliance Regulation Update XX Critical Points about Audits and Inspections XX Auditing Approach and Techniques XX Critical Element of Risk Assessment and Mitigation XX The Difference between Corrective Actions and Preventive Actions XX Common Errors in CAPA Management XX How to Measure Effectiveness of CAPAs PROGRAM CHAIR Hannah CHEN, MD Director, AP/China R&D, Quality Assurance, Janssen Pharm R&D Q&C, China PROGRAM COMMITTEE Helen LI, MD LEARNING OBJECTIVES XX Gain a better understanding of the GCP requirements and the challenges when deviations from requirements or non-compliance are possible or already observed XX Learn what tools can be used to detect non-compliance XX Better understand how the audit and inspection processes work XX Learn how to use auditing techniques as a tool in study management and monitoring XX Learn what the regulators expectations are in terms of CAPA management and CAPA completion XX Implement effectively CAPAs XX Learn how CAPAs are implemented successfully and what pitfalls must be avoided Director, Emerging Market QA, Asia Lead, Pfizer Medical - Quality Assurance, China Christina PING CEO, Chelsea Clinical Research, China KEY INSTRUCTOR Beat E. WIDLER, PhD Europe Clinical QA & Risk Management Expert, Widler & Schiemann Ltd., Switzerland Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA training material in any type of media, is prohibited without prior written consent from DIA. Metropolis Tower 7th Floor I Room #766 I No.2 Haidian Dong San Street I Zhongguancun Xi Zone I Haidian District, Beijing 100080, China Tel. +86.10.6260.2240 | Fax. +86.10.6260.2201 | www.diachina.org | [email protected] DAY ONE | THURSDAY, FEBRUARY 27 DAY TWO | FRIDAY, FEBRUARY 28 07:30 – 09:00 REGISTRATION 09:00 – 10:30 09:00 – 09:05 WELCOME AND INTRODUCTION Hannah CHEN, MD Director, AP/China R&D, Quality Assurance, Janssen Pharma R&D 09:10 – 09:30 DIA INTRODUCTION Jane CAI, PhD Director, DIA China 09:30 – 10:00 GLOBAL GCP COMPLIANCE REGULATIONS, NEW TRENDS AND TOT TOPICS Beat E. WIDLER, PhD Europe Clinical QA & Risk Management Expert, Widler & Schiemann Ltd., Switzerland 10:00 – 10:30 Beat E. WIDLER, PhD Europe Clinical QA & Risk Management Expert, Widler & Schiemann Ltd., Switzerland • • • • • CAPA as a Critical Element of Risk Assessment and Mitigation What You Need to Know About CAPA and GCP Compliance Describe the Difference Between Corrective Actions and Preventive Actions Common Errors in CAPA Management When are CAPAs Completed, How to Measure Effectiveness of CAPAs 10:30 – 10:45 TEA BREAK 10:45 – 12:00 CORRECTIVE ACTIONS AND PREVENTIVE ACTIONS (CAPA) - II 12:00 – 13:00LUNCH CHINA GCP COMPLIANCE REGULATION UPDATE WANG Jiannan Assistant Pharmacist, Inspection Division I, Center for Certification of Drug, State Food and Drug Administration 10:30 – 10:45 CORRECTIVE ACTIONS AND PREVENTIVE ACTIONS (CAPA) - I GROUP PICTURE AND TEA BREAK 13:00 – 15:00 CASE STUDY & GROUP EXERCISE 15:00 – 15:15 TEA BREAK 15:15 – 16:30 10:45 – 12:00 CASE STUDY & GROUP EXERCISE (CONT’D) WHAT YOU ALWAYS WANT TO KNOW ABOUT AUDITS AND INSPECTIONS? 16:30 – 16:50QUIZ Beat E. WIDLER, PhD Europe Clinical QA & Risk Management Expert, Widler & Schiemann Ltd., Switzerland 12:00 – 13:00LUNCH 13:00 – 14:00 EMA AND FDA INSPECTION Beat E. WIDLER, PhD Europe Clinical QA & Risk Management Expert, Widler & Schiemann Ltd., Switzerland 14:00 – 14:30 CFDA INSPECTION Hannah CHEN, MD Director, AP/China R&D, Quality Assurance, Janssen Pharm R&D Q&C, China 14:30 – 15:00 CASE STUDY & GROUP EXERCISE • How to prepare for an audit & inspection • Defining the purpose of an audit • Planning for the audit • Auditing approach and techniques: how to find what went or could go wrong 15:00 – 15:15 TEA BREAK 15:15 – 16:30 CASE STUDY & GROUP EXERCISE - CONT’D 16:30 – 16:50QUIZ 16:50 – 17:00 SUMMARY 17:00 END OF DAY 1 16:50 – 17:00 SUMMARY 17:00 END OF DAY 2 KEY INSTRUCTOR Beat E. WIDLER, PhD Europe Clinical QA & Risk Management Expert, Widler & Schiemann Ltd., Switzerland Dr. WIDLER is a biologist and obtained his PhD. in Microbiology from the Swiss Institute of Technology in Zurich, Switzerland, in 1982. He started his career in Pharma as a Drug Regulatory Affairs (DRA) manager. From 1986 to 2011 he was with Hoffmann-La Roche first as a DRA manager, then as clinical scientist and since 1993 in the International Clinical Quality Assurance department that he led from 1997 to 2011. Dr. WIDLER operates now as an independent Clinical QA and Risk Management Expert and is Managing partner of Widler & Schiemann AG, Switzerland. Dr. WIDLER is ISO 9001 certified and a registered Lead Auditor with the International Register of Certified Auditors (IRCA). Since April 2001, he is also holder of the SwAPP (Swiss Association of Pharmaceutical Professionals) Diploma for Pharmaceutical Medicine. Dr. WIDLER is an active member in a variety of international GCP working parties (e.g., EFPIA, IFPMA, DIA, EFGCP) and currently serves on the DIA Board of Direcors and as chair of the DIA Advisory Committee Europe. Dr. WIDLER regularly lectures at DIA, WHO, ECPM (University Basel) seminars and training courses and is a member of the IMI Pharmatrain syllabus committee. PROGRAM CHAIR Hannah CHEN, MD Director, AP/China R&D, Quality Assurance, Janssen Pharm R&D Q&C, China Hannah is currently QA director for Asia Pacific and China R&D in Janssen Pharma R&D, leading a team of 14 auditors based in Asian countries covering GCP, GLP and Pharmacovigilance (PV) audits. She joined Johnson & Johnson in September 2012 from GlaxoSmithKline (GSK). She has worked for GSK for more than 15 years, including 10 years in the area of compliance. She has also spent approximately 5 years in Clinical Research. Prior to joining GSK, Hannah worked for almost 8 months as a sales representative in Mead Johnson. Hannah has conducted a variety of GCP audits in majority of Asian countries, as well as US and European countries, LatinA and African countries. She also has experience in PV system audits and clinical lab audits. She has been involved in internal and external training programs. Hannah obtained her Medical Degree from Capital University of Medical Sciences in China and worked as a Pediatrician for years before joined industry in 1996. PROGRAM COMMITTEE Helen Q. LI, MD, MBA Director, Emerging Market QA, Asia Lead, Pfizer Medical - Quality Assurance, China Helen LI joined Pfizer global R&D (PGRD) in April 2008 and currently holds the position of QA Asia Lead at Pfizer Medical Quality Assurance. Helen’s primary responsibilities are to assure high quality clinical trials and regulatory compliance in Asia Pacific region by implementing Medical QA global strategy and delivering audit activities and other priorities in the region. Helen began her clinical research career at AstraZeneca Canada in Jan 1997, and has had increased responsibilities within Clinical Operations at AstraZeneca Canada and Asia/China. She advanced to global Clinical Quality Assurance (GCP focused) at AstraZeneca in the US since 2001 and has extensive clinical quality assurance auditing experiences in GCP audits at investigator sites, sponsor systems & processes and documents. Helen has presented at several international conferences in the healthcare industry, including: • Drug Information Association, DIA conferences in China and Korea • ExL Pharma, GCP Conference in the US Helen graduated from Fudan University, Medical School, in Shanghai majoring in Clinical Medicine. She has also studied RA/QA Master Degree program at Temple University, School of Pharmacy, Fort Washington PA, in the US. In 2012, Helen completed MBA at Fudan University, School of Management.