Wednesday, 29 May 2019
11:00 AM - 4:00 PM EDT
Over the past few years there has been a growing expectation and increased standardization for Quality Management Systems (QMS) as it relates to clinical research in the pharma industry. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 revision was just one example of a response to the need and demand for a more robust and documented system to ensure that procedures are established, and processes are in place to monitor compliance and analyze issues when they occur.
This program will address the growing requirements and expectations as it relates to root cause analysis, corrective and preventative action plans and implementation, aspects of a robust quality assurance program and how quality control can minimize errors and other quality issues. This program will support both the new and seasoned QMS manager or stakeholder to better understand the requirements, current industry trends for application and give them sample tools that can be used for quality management.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon conclusion of the program, you will be able to:
- Identify and interpret regulatory requirements and industry standards as it relates to the development and maintenance of a QMS.
- Provide input to a pharma organization regarding the rationale for a QMS including Quality Assurance and Quality Control programs.
- Understand the basic elements of a root cause analysis (RCA) and corrective and preventative action (CAPA) plan.
- Choose at least one tool for performing and documenting an RCA and/ or CAPA.
Who Should Attend?
- Quality assurance professionals
- Regulatory professionals
- Clinical professionals
- Vendor/ subcontractor personnel
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.RAPS Members:
Dipti Gulati, PhD, MBA, president & executive consultant, PJI Biotech
Dipti Gulati has over 20 years of experience in the healthcare industry, including 20 years in quality. Previously, she held various management positions at Amgen, Emergent Biosolutions, BioMeriux, Fijifilm Diosynth and SmithKline Beecham. Gulati is an organizing committee member for OMICS biosimilar conferences and a member of the PDA Regulatory and Quality Advisory Board. She has been instrumental in quality systems and data integrity assessment including remediation efforts overseas for last several years.
Treena Jackson, MS-QA/RA, MA, CQA, RAC, CSSGB, director, office of quality assurance, RTI Health Solutions
Treena Jackson is a consultant, instructor, author and director in the RTI Health Solution's Office of Quality Assurance. Jackson has been a quality professional for more than 17 years. Her experience includes managing quality and regulatory systems and projects in global pharmaceutical companies and contract research organizations while participating in a wide variety of therapeutic areas. She has also served as an independent consultant for pharmaceutical companies participating in domestic and international trial programs, supporting regulatory functions, as well as initiatives to develop and improve corporate quality-management programs.
Jackson has provided, developed and presented training programs to quality and research staff internationally. She has over 12 years of experience as a renowned adjunct professor, author and lecturer of quality, regulatory and clinical research topics for area universities and professional organizations. She currently teaches with Barnett International on both quality and regulatory topics.
Judy Zahora, PMP, MBA, director of clinical development compliance, Sarepta Therapeutics
Judy Zahora is director of clinical development compliance, SOPs and disclosure with Sarepta Therapeutics. She has over 30 years experience working in Quality Assurance, process improvement, IT and FInance. Zahora has developed and implemented compliance metrics to assess performance of global quality standards. She teaches for the Quality College of the Society of Quality Assurance (SQA), is the current vice president of the New England Regional Chapter of the SQA and is also the vice-chair of SQA's Beyond Compliance Specialty Section.
Benjamin Zegarelli, associate, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.
Benjamin Zegarelli is a member of the Mintz FDA practice team. He provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Zegarelli advises a broad range of healthcare and life science industry clients on the federal and state laws surrounding medical product development, manufacturing and marketing. He holds an MS in organic chemistry from the California Institute of Technology and a JD from the Benjamin N. Cardozo School of Law.