Each Spring, NJPQCA holds a full day educational conference with the FDA.
We are pleased to announce that the 2021 NJPQCA-FDA Conference, held virtually on May 18, 2021, was a success!
We had an exciting mix of FDA speakers as well as highly-respected Industry experts! Colleagues from across the country joined us! Thank you to all the speakers and attendees.
Attendees listened and interacted with FDA Speakers:
and Industry SME/Ex-FDA:
Monika Bagga and Peter Smith
Quality Risk Management
KASA (Knowledge-Aided Assessment and Structured Application)
|10:00 AM – 10:10 AM||Welcome and Opening Remarks||Sonande A. Shah, Associate Director, Global Strategy Change and Continuous Improvement in Cell Therapy, BMS and Michael Spangler, Principal Consultant, Spangler Consulting LLC|
|10:10 AM – 10:30 AM||Inspection Trends||Helen Verdel, Drug Specialist, Investigator Consumer Safety Officer, NJ FDA|
|10:30 AM – 11:00 AM||Application of Quality Risk Management, the Challenges & Opportunities||Monika Bagga, Associate Director, Quality Risk Management, Bristol Myers Squibb|
|11:00 AM – 11:10 AM||Break|
|11:10 AM – 11:40 AM||Overseas Inspections||Adetutu Gidado, Drug Specialist, Investigator Consumer Safety Officer, NJ FDA|
|11:40 AM – 12:10 PM||Remote/Virtual Audits||Peter Smith, Principal Consultant, Smith Consulting Group|
|12:10 PM – 12:40 PM||Break|
|12:40 PM – 1:10 PM||Knowledge-Aided Assessment and Structured Application (KASA): Opportunity for Modernizing Regulatory Assessment and Submission||Lawrence Yu, Ph.D., Director Office of New Drug Products, FDA|
|1:10 PM – 2:00 PM||Q&A Panel Discussion and Closing Remarks|
Helen Verdel – Drug Specialist, Investigator, Consumer Safety Officer, at NJ District Office
Helen serves as an Investigator within the Office of Regulatory Affairs (ORA), FDA, performing risk-based domestic and foreign inspections. She has audited ~40 foreign firms throughout the world (e.g., China, India, Taiwan, Singapore, Japan, UK etc.). Her inspections cover Pre-Approval (PAI), Active Pharma (API), finished dosage manufacturing facilities, testing laboratories, domestic audits of Pharmacy Compounding and Outsourcing Facilities. In addition, Helen trains and mentors junior/newly hired FDA Investigators. She also volunteers as FDA’s District Photographer capturing unforgettable memories of all district Official and Unofficial events.
Prior to joining the FDA, Helen held positions in the pharmaceutical industry as a Senior Auditor and Specialist. She holds a MS degrees in both Chemistry and Chemical Engineering.
Monika Bagga – Global Process Lead, Quality Risk Management, Bristol Myers Squibb
Monika brings 17 years of diverse and international experience across multiple industries and organizational cultures. She has extensive GxP experience in Quality Management Systems, business process alignment, data integrity, and risk and compliance management.
In her current role as the Global Process Leader, Monika continues to focus on embedding key Quality Risk Management (QRM) processes within assigned GxP areas (e.g. GLP, GMP, GDP) for biologics, small molecules, and devices. and partnering with network of Process Owners and Subject Matter Experts to ensure efficiency and effectiveness of the QRM operating Model.
In her previous position at GS1 Global, Monika was accountable for defining, operationalizing, and enforcing Quality Management best practices centered on comprehensive and sustainable enterprise-wide solutions across a variety of industries including life sciences, healthcare, and manufacturing. She established a risk assessment framework, policies, and directives which enabled data quality, integrity, governance, and security management ensuring cross-functional alignment of GS1 Global’s business strategy and execution on optimal enterprise solutions.
Prior to joining GS1, Monika served as the Business Quality Oversight Leader at Sanofi where she was instrumental in delivering an effective QMS supported by the harmonization of quality systems, ways of working, simplification of processes, and monitoring of quality performance metrics for various therapeutic areas. In this role, she promoted a culture of quality across a diverse group of stakeholders to ensure applications and processes were compliant with GxP regulations. Monika was also responsible for Inspection Management and Readiness Activities across Sanofi’s North America Quality organization.
Adetutu Gidado – Drug Specialist, Investigator Consumer Safety Officer at NJ District Office
Investigator Adetutu Gidado was sworn in as a Consumer Safety Officer in 2015. She currently serves as a Drug Specialist within the FDA’s Office of Pharmaceutical Quality Operations, Division 1. Her responsibilities include conducting investigations of complaints and entities engaged in distribution of products making therapeutic claims, inspections, and related regulatory enforcement activities on behalf of the agency. Ms. Gidado also conducts inspections of foreign establishments under various programs, which include countries operating under an MRA as well as countries with lesser developed regulatory systems.
She holds an undergraduate degree in Biochemistry from Lagos State university in Nigeria, and Masters in Regulatory Science from John Hopkins University in Maryland. Prior to joining the agency, she was employed by several pharmaceutical companies as a quality assurance and laboratory scientist.
She is the author of publications including Nutritional Status of Undergraduates in a Nigerian University in South-west Nigeria, published in the International Journal of Medicine and Medical Sciences, Vol. 1 (8), pp. 318-324, August 2009.
Peter Smith – Principal Consultant, Smith Consulting Group
Peter founded Smith Consulting Group after retiring from PAREXEL Consulting. Peter served for 23+ years in various PAREXEL positions including Vice President (Technical). He continues to support biologics and pharmaceutical consulting clients worldwide to achieve site facility compliance, implement GMP/Quality System corrective action plans, prepare clients for successful regulatory inspection outcomes, due diligence audits, and he conducts GMP audits and assessments. Peter is a highly regarded public speaker and trainer in GMP and FDA inspection readiness topics.
Before joining PAREXEL (then KMI) in 1994, Peter served 22-years in FDA positions. He worked in the field and at FDA headquarters as an Investigator specializing in pharmaceutical GMP/GCP and medical device inspections. His last position at FDA was Associate Director, International and Technical Operations Branch, Division of Field Investigations. In this capacity, he managed the FDA’s Foreign Inspection Program and conducted inspections of pharmaceutical plants worldwide.
Peter holds a BS in Biology from Roger Williams University, Bristol, Rhode Island. He is a member of PDA, ISPE, RAPS, and is an Associate Adjunct Professor at the University of Rhode Island, College of Pharmacy, teaching pharmacy students.
Lawrence X. Yu, Ph.D. – Director, Office of New Drug Products, FDA
Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, FDA, Silvers Spring MD.
As an Agency thought leader Dr. Yu implemented a Biopharmaceutics Classification System at the FDA, created the Question-based Review, described the Pharmaceutical Quality by Design (QbD), inaugurated the FDA modern review system – Integrated Quality Assessment (IQA), developed the FDA historic concept of operations agreement to integrate review and inspection, and originated the Knowledge-aided Assessment and Structured Applications (KASA).
Dr. Yu also serves as an adjunct Professor at the University of Michigan. His compartmental absorption and transit (CAT) model laid the foundation for the widely used commercial software, GastroPLUSTM and Simcyp®. Dr. Yu is a fellow and the past section Chair of the AAPS and an Associate Editor of the AAPS Journal. Dr. Yu authored/co-authored over 150 papers and given over 400 invited presentations. He is a co-editor of Biopharmaceutics Applications in Drug Development, FDA Bioequivalence Standards, and Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, 2nd Ed.