COURSE DESCRIPTION

OVERVIEW

Small to midsize pharmaceutical and biotech companies are enjoying the best of times.  Exciting science, fantastic preclinical and/or clinical results, great platforms for long-term company growth, and support from intellectual/academic experts offer seemingly endless opportunity.  However, from a quality systems perspective, these may be the worst of times for small pharma.  Many start-up or small firms have weak clinical quality management systems (QMS), are not following global regulatory authority regulations, and/or guidance or lack the level of documentation required to reconstruct – and defend – every aspect of clinical trials.

So, what is a small pharma company to do?  First, you must ensure that your basic quality systems are understood and embraced from the top to bottom of your organization.  It is critical to establish a foundation of support for internal compliance and appropriate vendor oversight throughout the life of your clinical program…right through regulatory market approval and launch. Even if you outsource 99 percent of GCP activities, you are the sponsor, and you are responsible.   Global regulators require your company to have a robust QMS, regardless of your company size or the size of your vendor(s).

This course will provide practical solutions for how to establish a basic, compliance QMS that will include the following key ingredients:

• Company Quality Policy
• Quality Plans, and/or Quality Manuals
• Program Governance and Oversight
• Quality Assurance/Quality Control
• Vendor Management
• Controlled Documented Processes
• Documented Risk-based Approaches and Processes
• Documentation of Training
• Electronic Systems Validations
• Issue Management and Escalation

Most importantly, you will obtain practical solutions for how to establish and document a comprehensive QMS strategy, from initial groundwork to implementation and continuous improvement.

LEARNING OBJECTIVES

At the completion of this session, you will be able to:

• Establish the most basic required elements of a Clinical QMS (regardless of outsourcing model)
• Create a “Quality Strategy Plan” using a template provided with the training
• Prioritize establishment of basic processes and appropriate documentation
• Implement the basic processes needed for a Clinical QMS
• Find relevant examples and other resources to support QMS creation