How to Establish and Maintain a Compliant, Practical Clinical Quality Management System in a Changing Organization

Instructor: Penelope Przekop
Product ID: 706062
Training Level: Intermediate
  • Duration: 90 Min
Global regulators require your company to have a robust QMS, regardless of company size, situation, or outsourcing strategy. In this webinar, learn how to establish and maintain a compliant and practical Clinical Quality System during process improvement efforts and/or company growth that can be clearly understood, communicated, and embraced from the top to bottom of your organization.
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The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1.5 hours of CE credit.

Why Should You Attend:

It’s critical to establish and maintain a clear foundation 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, are entrenched in organizational change, etc., you are the sponsor, and you are responsible. Global regulators require your company to have a robust QMS, regardless of company size, situation, or outsourcing strategy.

Global regulators are expanding their focus on Clinical Quality Systems as evidenced ICH E6 R2. Having a strong, documented quality system ensures that processes are in place to enable companies to not only fully define, evaluate, and mitigate their own compliance to regulatory requirements, guidelines, and industry standards but to also demonstrate that of their vendors. With a robust Clinical Quality System, companies can see, describe and discuss the big picture of how they are ensuring that data is of high integrity and that patients are safe.

There has been a surge in small to midsize pharmaceutical and biotech companies over the last ten years. That surge coupled with the growing vendor industry has created a new normal, including an increase in the number of management-level positions in all areas. There are exciting times for the industry; however, this evolution is creating some gaps in experience when it comes to quality and compliance management.

From a quality systems perspective, the industry requires a growth mindset in terms of understanding how to develop quality systems that will enable us to continue to have and provide assurance of data integrity and patient safety. This webinar will show how to develop a robust clinical quality management system, maintain compliance with global regulations and guidelines of regulatory authorities, and have a level of documentation required to reconstruct – and defend – every aspect of clinical trials.

Attend this webinar to gain practical solutions 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.

Areas Covered in the Webinar:

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

  • Understand what is required to establish the most basic elements of a Clinical QMS (regardless of outsourcing model)
  • Create a “Quality Strategy Plan”
  • Prioritize establishment of basic QMS processes and appropriate documentation
  • Find relevant examples and other resources to support QMS creation

Who Will Benefit:

This course will benefit employees of all levels within 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
Instructor Profile:
Penelope Przekop

Penelope Przekop
CEO, PDC Pharma Strategy

Penelope Przekop is a Pharma R&D & PV Quality Systems Engineer and Quality Assurance/ Systems & Compliance Consultant with more than 25 years of experience in Pharmaceutical & Biotech GXP Global Quality Systems. My growing consulting focus is the development and implementation of practical, risk-based quality systems/compliance strategies for pharma and biotech companies that support corporate goals not only during development but also through submission, product launch and beyond.

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Seminars by Ex-FDA Officials
Investigational New Drug (IND) & Investigational Device Exemptions (IDE)

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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