How to Effectively Conduct GCP Audit and Inspections February 27-28, 2014 Beijing, China

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.