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

Regardless of your Company size, situation, or outsourcing strategy, Global regulators require your company have a robust Quality Management System (QMS). Your Clinical Quality System must be compliant and practical. This webinar will help you establish and maintain a Clinical Quality System that can be clearly understood, communicated, and embraced from the top to bottom of your organization during process improvement efforts and/or company growth.

Live Online Training
July 18, Thursday 10:00 AM PDT | 01:00 PM EDT (90 Min)

$249.00
One Dial-in One Attendee
$629.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Recorded Version

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section 48 hrs after completion of Live training

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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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:

Establishing and maintaining a clear foundation for internal compliance and relevant vendor oversight throughout the life-cycle of your clinical program … right through regulatory market approval and launch is highly important. As the sponsor, you are responsible even if you outsource 99 percent of your clinical program, or are deep into organizational change, etc. A robust QMS is a must requirement by Global regulators regardless of company size, situation, or outsourcing strategy.

Global regulators are increasing their emphasis on Clinical Quality Systems as evidenced ICH E6 R2. By maintaining a strong, documented quality system, you demonstrate that processes are in place to allow companies fully define, evaluate, and mitigate their own compliance to regulatory requirements, guidelines, and industry standards and to that of their vendors. Having a robust Clinical Quality System, will enable companies to see, define and discuss the big picture of how they are making sure that data is of high integrity and that patients are safe.

The number of small to midsize companies in pharmaceutical and biotech companies are increasing over the last decade. This increase clubbed with the growing vendor industry has formed a new normal, including a surge in the number of management-level positions in all fields. Although exciting times for the industry, this evolution is creating some gaps in experience when it comes to quality and compliance management.

From a quality systems perspective, the industry must take a growth approach to understanding how to build quality systems that will allow us to provide ongoing assurance of data integrity and patient safety.

This webinar will show how you can develop robust quality management systems (QMS), abide by the global regulatory authority regulations and guidelines, and have the 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, RQAP-GCP, is a Quality Management Systems, Assurance & Compliance Consultant with 25 plus years of experience in Pharmaceutical GXP Global Quality Systems with key focus in clinical development, data management and pharmacovigilance. Her areas of expertise include quality systems quality assurance, regulatory compliance, inspection readiness, training, and strategic planning.

Penelope earned a BS in Biological Sciences from Louisiana State University and an MS in Quality Assurance/Systems Engineering from Kennesaw State University. She has held leadership positions in both big pharma and Contract Research Organizations, including Johnson & Johnson, Wyeth Pharmaceuticals, Novartis, and Covance.

She is the author of Six Sigma for Business Excellence (McGraw-Hill) and is a past columnist for Pharmaceutical Manufacturing Magazine. In addition, she is a frequent speaker on topics of quality management systems, regulatory compliance, and overcoming obstacles in both business and life through the application of quality management principals and strategies.

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. FDATrainingAlert 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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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