10 Steps to Perfect SOPs: FDA Compliance made easy

Duration: 60 Minutes
Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand.
FDA guidance document
Instructor: Mukesh Kumar
Product ID: 500164
They are frequently poorly written, communicated, monitored and enforced. This seminar will provide step by step instructions to create SOPs for FDA-regulated organizations. The author will discuss case studies and examples to highlight the common errors and potential solutions. Additionally, the logistics of creating, maintaining, scope, training and documentation will be reviewed. Pros and Cons of paper and electronic SOPs will also be discussed. This seminar contains a collection of practical tips from the trainer’s extensive FDA audit experience.

Why Should you Attend:
This seminar will help you evaluate your current SOPs for the presence of most common issues identified by FDA during audits. You will get practical tips and tested strategies for creating, revising, updating, training, and documenting SOP processes at your organization. The case studies will highlight the key concepts, alternate methods, and least-burdensome approach to compliance with FDA regulations.

Objectives of the Presentation:
  • Essential elements of an SOP
  • Process mapping techniques to define the contents of an SOP
  • Role of personnel in creating SOPs
  • SOP revisions, updates, creation, retirement and documentation
  • Categorization of SOPs
  • Assessment of compliance techniques
  • Training practices for FDA compliance
  • Access and access control to SOPs
Who can Benefit:
  • QA/QC/compliance/regulatory professionals
  • Senior Management Executives (CEO, COO, CFO, etc)
  • Manufacturing Managers, Supervisors and Personnel
  • Clinical and Preclinical Laboratory Managers
  • Clinical Trial Specialists
  • Project Managers
  • People Investing in FDA-Regulated product development projects
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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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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