12 March 2019
11:00 am – 4:00 pm EDT
Webcast registration includes access to handouts, presentation
slides and the on-demand recording for one year.
Register By 11 Feb
Register After 11 Feb
RAPS Members: $295
RAPS Members: $395
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
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
Treena Jackson, MS-QA/RA, MA, CQA, RAC, CSSGB,
quality assurance manager, RTI Health Solutions
Treena Jackson is a consultant, instructor, author and a
Quality Assurance Manager in the RTI‑Health Solution 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.
Additional Speakers TBA