Clinical Quality Management Systems (QMS): Establishing a Practical & Compliant Program


Many small to mid-sized biotech and pharmaceutical companies possess exciting science, promising products, and endless opportunity.  However, most lack the kind of robust clinical Quality Management Systems (QMS) required by global health authorities.  Since patients and profits are at risk, it is critical to establish these systems for market approval and patient safety.  This course will give you the necessary tools to establish a working and compliant QMS for your business.




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.


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


This course will benefit employees of all levels within small to mid-sized biopharmaceutical companies that are developing and executing global and/or domestic CGP-regulated clinical research and development programs and trials. Senior managers responsible for overall clinical research and development strategy will benefit as well as employees managing clinical trials, clinical quality assurance, the inspection process, and/or develops/manages processes that fall under GCP expectations. This includes personnel in:

  • Strategic Leadership Positions
  • Clinical Development
  • Clinical Research
  • Quality Assurance
  • Vendor Management
  • Other functions which may be subject to regulatory authority audits



This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.


Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.


Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

Additional information


Recorded Only


Single Participant, 5 Participant Value Package, 10 Participant Value Package


  1. Anuprita

    Its good insights

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