Presented by Celeste M. Gonzalez

 

In order to evaluate the trial conduct and compliance with quality systems, SOPs, protocols, good clinical practices, and other applicable regulatory requirements, the FDA reserves the ability to audit or examine an investigator study at any time. Anxious anticipation has begun to spread throughout the industry due to the many recent modifications to the applicable regulatory and compliance guide¬lines. When, how, and why these audits will take place are necessary considerations in ensuring proper preparation for what may be an increase in future FDA auditing in investigator initiated research.

  • Ensuring studies and sites are audit ready
  • Circumstances that can lead to inspections
  • Post-inspection strategies: moving forward

Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Investigator Initiated Research
  • Medical Affairs
  • Clinical Affairs & Operations
  • Auditors
  • Quality Assurance

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Celeste

 

 

 

 

 

 

Celeste M. Gonzalez, RQAP-GCP
Senior Clinical Quality Assurance Consultant

 

 

Celeste M. Gonzalez is a Senior Clinical Quality Assurance Consultant in the life science industry. She has conducted over 300 clinical investigator site audits, over 75 clinical, bioanalytical, and GLP laboratory audits, over 75 vendor audits including contract research organizations (CROs), site management organizations (SMO’s),  call centers, e-diaries, core laboratories, central imaging and central reading services, drug and device packaging and distribution, computer applications hosting, institutional review boards, and commercial archives, over 50 clinical database audits, over 150 clinical protocols, ICFs, eCRFs/CRFs, study reports, annual reports and attendant statistical reports, and over 40 internal systems audits.Her background has enabled her to develop multiple GCP and GLP training programs, as well as an on-demand web-based clinical investigator site BiMO inspection readiness training program.

 

 

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