Developing Practical and Successful GCP and GVP Audit & Inspection CAPAs

Penelope Przekop

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This Webinar will focus on how to use SMART goals as a framework to draft submission-ready GCP and/or GVP CAPAs that not only adequately address observations but are also practical given your organization’s unique goals and challenges. Anecdotes and examples will be provided to lend context, and tools shared to give you the confidence to write successful CAPAs.

Why Should You Attend:

How CAPAs are written is key for gaining agreement with internal Quality Assurance Groups, clients and/or regulatory authorities. Poorly-written CAPAs can lead to confusion and – worst of all – repeated observations. In a pharmaceutical GCP and GVP environment, just about any group, team, or individual can find themselves in the hot seat during audits and regulatory inspections. Despite all audit and inspection readiness efforts, an outcome of zero audit observations are rarely seen. Companies are less likely to receive an official list of minor inspection observations to which they must respond; however, we all dread being handed major or critical observations from regulators.

If faced with that scenario, after the initial shock of your observations wears off, robust Root Cause Analysis (RCA) is conducted and an appropriate Corrective and Preventative Action (CAPA) is determined. After all that work, one of the worst possible outcomes is having a repeat major or critical audit or inspection observation because your CAPA failed to address the issue.

This Webinar will provide specific instruction, tips, and tools on how to use SMART (Specific, Measurable, Achievable, Results Oriented, and Time-Bound) goals as a framework to draft submission ready GCP and/or GVP CAPAs that:

  • Adequately address observations
  • Are practical for your organization
  • Are comprehensive and clear
  • Do not waste organizational time and effort
  • Support inspection readiness
  • Are appropriately managed following industry and regulatory standards
  • Help avoid follow up or repeated observations
  • Provide assurance that your organization has the insight and ability to understand your issues and/or gaps and can effectively remediate them.

Areas Covered in the Webinar:

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

  • Appropriately interpret an observation (the first step to developing an appropriate response)
  • Identify the key expected elements of a great CAPA
  • Write a CAPA that is both grammatically correct and specifically addresses the observation
  • Use SMART (Specific, Measurable, Achievable, Results Oriented, and Time-Bound) goals to craft your CAPA
  • Select appropriate CAPA owners and timelines to ensure that the observation can be tackled and closed out within a reasonable timeframe

Who Will Benefit:

This course will benefit employees of all levels within biopharmaceutical companies that are developing and executing global and/or domestic CGP and/or GVP-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 (and postmarking) safety, clinical and PV quality assurance, the inspection process, and/or develops/manages processes that fall under GCP and GVP expectations. This includes personnel in:

  • Strategic Leadership Positions
  • Clinical Development
  • Clinical Research
  • Clinical Safety and/or Pharmacovigilance
  • Quality Assurance
  • Vendor Management
  • Other functions which may be subject to regulatory authority audits
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: 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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