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Creating Effective SOPs for Regulatory Compliance - Webinar

  • ID: 3450720
  • Webinar
  • Region: Global
  • 90 Minutes
  • Redstone Learning
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The topic of inadequate or missing Standard Operating Procedures (SOPs) continues to dominate the FDA's inspectional observations. They are found as one of top findings in warning letters and 483s, often lagging only behind the Quality Unit concerns. Having effective and compliant SOPs is not only a regulatory requirement but also makes good business sense. Effective SOPs provide a historical record for operational processes. Poor SOPs pose a great compliance risk. Also, SOPs are often used as training tools and as such, they need to be easily understood by all those whom they affect. Often employees fail to follow SOPs because they can't understand them. Too many times we have seen procedures that are being constantly revised. This then, results in lengthy and expensive investigations and costly revisions. Moreover, this leads regulators to believe that the organization does not operate in a state of control.

Course Objective:

By attending this webinar, you will gain a better understanding the regulatory expectations for, and the proper design and maintenance of Standard Operating Procedures. You will also learn how to create and review SOPs, and generate a system for training and implementation of both effective and FDA-compliant written procedures.

Target Audience:

- Directors
- Managers
- Professionals
- Technical writers and
- General staff with the responsibility for creating, reviewing and approving written standard operating procedures and instruction
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Course Outline:

- Why we need written procedures?
- FDA’s expectations for an effective written documentation.
- Regulatory requirements for the creation, compliance and maintenance of written procedures.
- Proven techniques for creating effective SOPs and other written documents to minimize costly revisions.
- Roles and responsibilities for the review and approval of written documents consistent with compliance requirements.
- System for training and implementation of written procedures.
- Control, archival and disposal of written procedures.
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Henry Urbach, is the founder of GMP Training, Development and Consulting (GMP TDC) LLC, a New York-based consulting organization serving Life Sciences industries. He has 20+ years of Life Sciences experience having held positions of increased responsibility in Training, QA, and QC Microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of remediation, and developing an environmental monitoring training program.

He is a dynamic speaker specializing in FDA and ICH compliance. He is a Certified Quality Auditor (CQA). His technical education is further complemented by his BA degree in Biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP Training and Education Association (GMP TEA).
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