PIC/S QRM Expert Circle 2020

PIC/S Expert Circle on Quality Risk Management (QRM) Webinar

September 24th, 2020

11:00 am-3 pm CET
Via Webinar

Register Online
About the Webinar

The Turkish Medicines and Medical Devices Agency (TMMDA) is pleased to host virtually by webinar the next PIC/S Expert Circle on Quality Risk Management (QRM) meeting on 24 September 2020.

Due to the COVID-19 situation, TMMDA has taken the decision to postpone the hosting of the QRM Advanced Training event planned on 22-24 September 2020 in Istanbul (Turkey).

The new dates for the QRM Advanced Training event in Istanbul will be planned for the second half of 2021.

The meeting of the Expert Circle of QRM will go ahead as a webinar on 24 September 2020 hosted by Turkey / TMMDA.

The webinar will have some training elements of QRM. As the webinar will be dedicated solely for GMP inspectors, it will serve as a good place to discuss updates and progress on applicable QRM guidance.

The webinar will be open to PIC/S Participating Authorities, Partners, (Pre)Applicants and non- PIC/S Member Medicines Regulatory Authorities.

PIC/S Expert Circle on QRM has been active in developing and running advanced training for GMP Inspectors to enable them to more effectively inspect the applicaton of risk assessment and QRM during inspections in a harmonised manner. It also enables them to effectively use the PIC/S Recommendation in relation to risk-based GMP inspection planning.

We look forward to seeing you in webinar.

Harun KIZILAY, Pharm.PhD.
Head of TMMDA

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Speakers
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Countries
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Participants
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Speakers

Kevin O’Donnell, Ph.D.

HPRA, Ireland

Chairman of PIC/S QRM Expert Circle

Kevin O’Donnell, Ph.D.

HPRA, Ireland

Chairman of PIC/S QRM Expert Circle

Kevin is Market Compliance Manager at the Health Products Regulatory Authority (HPRA, formerly known as the Irish Medicines Board), in Dublin, Ireland. He has been with the HPRA/IMB since 2001 and is a Senior GMP Inspector. He is also responsible for a number of compliance-related areas at the HPRA, including the Quality Defect and Recall programme, the Sampling and Analysis programme, and the Advertising Compliance programme. He obtained his PhD in the field of Quality Risk Management (QRM) from the Dublin Institute of Technology in 2008. He is currently Chair of the PIC/S Expert Circle on QRM.

Jacques Morénas

ANSM, France

Chairman of PIC/S Sub Committee on Training (SCT)

Jacques Morénas

ANSM, France

Chairman of PIC/S Sub Committee on Training (SCT)

Jacques Morénas was born in 1952 in Clermont-Ferrand (France) and carried out all of his studies there, including obtaining his pharmacist diploma in June 1977. He then directly entered the Ministry of Health and then passed the competition for become a pharmacist inspector in the field of Public Health. After a year of study in the School of Advanced Studies in Public Health in Rennes (France), he held different positions in this ministry, in offices in charge of the management of narcotics and then drugs for veterinary use. In 1983, he joined the local inspectorate for Public Health in Paris (France) until 1991. He then returned to the Ministry of Health, as deputy to the head of the pharmacist inspectors corps.

In 1993, he joined the newly created drug agency. For over 25 years, he held various positions, still in the field of inspection. In particular, for 18 years, he participated in the European construction of GMP inspection and in the development of the "Pharmaceutical Inspection Cooperation Scheme (PIC / S)" of which he was chairman for 4 years. He was also involved in the ICH Q9 and Q10 documents. He finished his career (full time) as deputy director of inspection in July 2018. He continues to work there part-time, as technical advisor to the director of inspection, on European subjects and international like ICH and PIC / S.

Jacques Morénas is also a member of the French National Academy of Pharmacy.

Ellen Ying-Hua Chen

FDA, Taiwan

Member of PIC/S QRM Expert Circle

Ellen Ying-Hua Chen

FDA, Taiwan

Member of PIC/S QRM Expert Circle

GMP Inspector and the Senior Specialist, Quality Compliance and Management Division, Taiwan Food and Drug Administration, Ministry of Health and Welfare, Taiwan R.O.C.

Ms. Ellen Ying-Hua Chen is a GMP inspector and the Senior Specialist within the Quality Compliance and Management Division (GXP Inspectorate) of the Taiwan Food and Drug Administration under the Ministry of Health and Welfare, Taiwan ROC. In this position, she is responsible for supervising the GMP compliance of manufacturers of medicinal products and medical devices, Good Tissues Practice compliance of cell/tissue-based products and Tissue/Cells banking, Good Practice compliance of blood establishment, and international cooperation affairs in the field of GMP/GDP for medicinal products. She has been working in the GXP inspectorate over 14 years after receiving an MBA in Technology & Innovation Management from National Cheng-Chi University in Taiwan. Before that, she graduated from Pharmacy School of Taipei Medical University in 1999; then, worked as a laboratory specialist in Pharmaceutical Chemistry, National Laboratories of Foods & Drugs, Department of Health, Taiwan ROC for about 3 years. She has been actively participating in international harmonization activities and has extensive experience working with PIC/S included being the Taiwan FDA representative in PIC/S.

Karmin Saadat

AGES, Austria

Member of PIC/S QRM Expert Circle

Karmin Saadat, Pharmacist, PhD.

AGES, Austria

Member of PIC/S QRM Expert Circle

AGES Austrian Agency for Health and Food Safety

Karmin Saadat is pharmacist, he had a PhD. from University of Vienna Institute of Pharmaceutical Medicinal Chemistry .

He joined to AGES in 2009. He is currently working GMP/GDP inspections, third countries (human plasma and APIs), joint inspections and domestic inspections. Lead Inspector for non sterile manufacturing, APIs, repackaging, distributors, chemical/physical laboratories, biological laboratories, blood establishments.

He is head of Plasma and Blood Group within the GMDP department. Member of the Blood Comission“ (to consult Federal Ministry of Health in regards to blood legislation)

Participation as an expert at competent authorities meetings on blood and blood components at the European Commission.

Ileana Barreto-Pettit

FDA, USA

Member of PIC/S QRM Expert Circle

Ileana Barreto-Pettit, R.N., M.P.H.

FDA, USA

Member of PIC/S QRM Expert Circle

FDA Drug National Expert

U.S. Food and Drug Administration (FDA)

Captain Barreto-Pettit is currently an FDA Drug National Expert and a member of the FDA Pharmaceutical Inspectorate. She is responsible for conducting the most complex domestic and foreign cGMP and Pre-Approval inspections of pharmaceutical drug manufacturers. She joined FDA in 1999 as an Investigator in the FDA San Juan District in Puerto Rico and transferred to the Florida District in 2003. Since then, she has conducted hundreds of inspections of drug, device, and dietary supplement manufacturers in the U.S., Caribbean, Europe and Asia. CAPT Barreto-Pettit has been a trainer of new drug investigators in the FDA Basic Drug School for the last 13 years and she is a frequent Speaker at pharmaceutical industry conferences. She is a Commissioned Officer in the U.S. Public Health Service and has over 34 years of experience in the federal government. She received a B.S. in Biology from Iowa State University, a B.S. in Nursing from Jacksonville State University, and a Master’s in Public Health from Nova Southeastern University.

Rick Friedman

FDA , USA

Member of PIC/S QRM Expert Circle

Rick Friedman

FDA , USA

Member of PIC/S QRM Expert Circle

Richard L. Friedman is the Deputy Director, Science and Regulatory Policy, Office of Manufacturing Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER).

In this position, he is responsible for oversight of drug manufacturing quality issues and GMP compliance. This position includes review of regulatory action recommendations regarding inspections and manufacturing site acceptability, and promoting sound regulatory policy development.

Mr. Friedman joined FDA in 1990 and his positions have included New Jersey District Drug Specialist, CDER Senior Compliance Officer, Team Leader of Guidance & Policy, Associate Director, and Division Director.

Mr. Friedman has authored several publications on topics including sterile drugs and quality systems, and was awarded The George M. Sykes Award by the Parenteral Society for outstanding journal paper for the year 2005.

He also received the 2011 Kenneth Chapman Achievement Award from the Institute of Validation Technology, and the 2012 Gordon Perseneus Award from PDA for scientific contributions to pharmaceutical quality.

Mr. Friedman has been an adjunct faculty member of Temple University School of Pharmacy in their QA/RA graduate program since 2003. Prior to joining FDA, Mr. Friedman worked in the toxicology research division of Parke-Davis.

Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.

Graham Carroll

MHRA, UK

Member of PIC/S QRM Expert Circle

Graham Carroll

MHRA, UK

Member of PIC/S QRM Expert Circle

Graham Carroll joined the MHRA as a GMDP Inspector in 2013 before becoming a GMDP Operations Manager in 2017. In 2019 he also became a Senior Inspector. Prior to joining the MHRA he spent eight years working in the pharmaceutical industry in the areas of human plasma fractionation and sterile product manufacturing; this included operational and managerial roles in Validation and Quality Assurance. This included the design, development and delivery of new quality system tools for the management of deviations, CAPA, change controls and customer complaints, incorporating quality risk management (QRM) principles.

Graham specialises in the inspection of sterile product manufacture as well as the collection, processing and supply of blood and blood components. He is the MHRA Inspectorate lead for a range of topics including QRM, antimicrobial resistance and GMP risk-based inspection scheduling.

Fazillahnor Ab Rahim

NPRA, Malaysia

Member of PIC/S QRM Expert Circle

Fazillahnor Ab Rahim

NPRA, Malaysia

Member of PIC/S QRM Expert Circle

Ms. Fazillahnor Ab Rahim joined the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health on 1st June 2005 and has work with the GMP section for 14 years. She was first appointed as GMP inspector on 1st Feb 2007 after completing her term as Provisional Registered Pharmacist (PRP) and training in GMP inspection.

She is appointed as Lead GMP Inspector on 1st February 2010 and headed GMP Section for Biopharmaceutical and Biological Establishment Premises from the year 2012 to 2017. During her tenure supervising this section, she has established Inspection framework for Blood Establishment in year 2012, Good Tissue Practice Guideline for Cell and Gene Therapy products in year 2014 to support the agency’s regulatory framework and Site Master File for Blood Establishment Guideline in 2016. In April 2017 to Dec 2019, she has been assigned to head the GMP Section for Complementary and Hospital Establishment where during this time she had her first involvement in ASEAN Traditional Medicine and Health Supplement (TMHS) Product Working Group and chaired in few series of the ASEAN TMHS GMP Task Force.

Other notable works that she has contributed to the agency are develop GMP Desktop Assessment (GDA) for foreign manufacturer, desktop assessment for foreign TMHS manufacturer to address GMP equivalency and co-author the Good Compounding Practice Guideline. She also has received Excellence Service Awards (Year 2011 and 2016) from Ministry of Health Malaysia.

At present, she is still actively conducting GMP inspection to sterile, biopharmaceuticals/biologicals and non-sterile manufacturer, including complementary products and cosmetics manufacturer.

Hiroshi Sakurai

PMDA, Japan

Member of PIC/S QRM Expert Circle

Hiroshi Sakurai

PMDA, Japan

Member of PIC/S QRM Expert Circle

Technical Requirements

The zoom infrastructure is used in the webinar to be performed. In order to avoid facing a technical problem, please make sure that the zoom application is installed on the computers you will join the webinar and the necessary permissions are given in the firewalls.

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Agenda
11:00-11.05am
WelcomeHarun KIZILAY - Head of TMMDA
11:05-11:10am
Introductions Co-chairs, Gülşen Yılmaz (TMMDA) and Kevin O’Donnell (HPRA)
11:10-11:20am
Review of the Current Mandate of the Expert Circle and overview the work done to date
Ellen Chen (Taiwan FDA)
11:20am-12:00pm
The PIC/S Aide Memoire on inspecting the implementation of QRM
Discuss the revision work that is in progress
Seek feedback on what the revised Aide Memoire should address
Rick Friedman (USFDA) & Hiroshi Sakurai (PMDA)
12:00pm-12:10pm
Break
12:10pm-12:55pm
The QRM curriculum and the QRM e-Module from the PIA – How might Inspectorates use these items?
Karmin Saadat (AGES) & Ileana Pettit (USFDA)
12:55pm-1:15pm
Break
1:15pm-1:45pm
The 2019 PIC/S Recommendation Paper on Evaluating and Demonstrating the Effectiveness of the Pharmaceutical Quality System (PQS) with respect to Risk-based Change Management
Kevin O’Donnell (HPRA) & Rick Friedman (USFDA)
1:45pm-2:00pm
Training on ICH Q12 and the value of the PIC/S Recommendation Paper on Evaluating and Demonstrating the Effectiveness of the Pharmaceutical Quality System (PQS) with respect to Risk-based Change Management
Jacques Morenas (ANSM)
2:00-2:10pm
Break
2:10pm-2:55pm
Q&A on the above
Graham Carroll (MHRA) & Fazillahnor binti Ab Rahim (NPRA)
2:55pm-3:00pm
Closing Remarks
Co-chairs, Gülşen Yılmaz (TMMDA) & Kevin O’Donnell (HPRA)
Contact Us

Inspectorate

Turkish Medicines and Medical Devices Agency
Ministry of Health
06520 Ankara, TURKEY
2020QRM@titck.gov.tr