Critical SOPs for Clinical Sites

Duration: 60 Minutes
Clinical sites frequently struggle to understand FDA expectations regarding quality systems that should be in place to demonstrate compliance with good clinical practices. Experiences from FDA audits have shown that many clinical sites lack adequate systems and procedures for ensuring the good quality clinical trial conduct.
clinical compliance
Instructor: Mukesh Kumar
Product ID: 500028
Recent FDA guidance documents suggest that clinical investigators develop standard procedures (SOPs) for key activities conducted at their site and assure that staff members (e.g., subinvestigators and clinical research coordinators) appropriately follow the same. Several industry organizations have similarly proposed multiple SOPs that are critical for maintaining quality procedures at clinical sites.

This webinar will highlight which SOPs should be implemented and what methods should be used to develop and document FDA-acceptable conduct of clinical sites activities. The author would address the competing opinions available from various sources about both topic selection and the depth of coverage or detail that is required. In this interactive session, the presenter would share his experience in site management and procedure development. Participants will leave the session with tools to help them assess what is appropriate for their practice setting and an action plan for addressing their site's specific needs.

Why Should you Attend:
If you are a hospital, clinic, individual physician, nurse, clinical trial professional or a sponsor of a clinical trial, this webinar will provide valuable suggestions about which SOPs should you develop, how should you train your staff, what kind of documents should you create to demonstrate your compliance with FDA regulations, and tips for troubleshooting common issues. Also discussed will be issues related to products being tested, responsibilities of individuals, resources available, and projected trends for the near future.

Objectives of the Presentation:
At the end of this webinar, you would understand:
  • Current FDA expectation from clinical sites
  • List of key SOPs critical to demonstrate GCP compliance
  • Best practices related to SOP development and maintenance by clinical sites
  • Current industry practices for SOPs
  • Common issues with FDA audit for site processes.
Who can Benefit:
  • Clinical Research Associates (CRAs)
  • Clinical Research Coordinators (CRCs)
  • Clinical Research Administrators
  • Data Managers
  • Principal Investigators
  • Project Managers
  • Sponsors of INDs
  • People investing in FDA-regulated product development projects
$300
Recorded Session for one participant
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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