Creating Effective SOPs for Regulatory Compliance

Why Should You Attend:

The lack of or inadequate standard operating procedures (SOPs) continue to dominate the FDA's inspectional observations. Their frequency lags only behind the quality unit concerns. Moreover, SOPs are often used as training tools, which means that they need to be easily understood by all those whom they affect. Effective SOPs are not only a regulatory requirement; they also make good business sense. Too many times employees fail to follow SOPs because they can't understand them, and too many times procedures are being constantly revised. This leads to lengthy and expensive investigations and costly revisions.

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

Areas Covered in the Webinar:

• Why do we have written procedures?
• What does FDA expect from our 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.
• An effective review and approval process compliant with regulatory requirements.
• A system for training and implementation of written procedures.
• A system for the control, archival, and disposal of written procedures.

Who Will Benefit:

• QA/ QC
• Regulatory affairs
• IT/ IS
• Technical writers
• General staff with the responsibility for creating, reviewing and approving written standard operating procedures and instructions

Instructor Profile:

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 GMP Training and QC Microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of a post-regulatory action remediation, and developing an environmental monitoring training program for major pharmaceutical and biotechnology organizations. He is a dynamic speaker specializing in FDA and ICH compliance. He is a Certified Quality Auditor. 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 TEA, a national organization of Life Sciences training professionals.

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