Creating Effective SOPs for Regulatory Compliance
Wednesday, October 5, 2016 from 10:00 AM to 11:00 AM (PDT)
San Francisco, California
London, United Kingdom
This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).
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
Henry Urbach is a founder of GMP Training, Development and Consulting (GMP TDC) LLC, a New York-based consulting organization serving life sciences industries. He has over 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 a post-regulatory action 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 TEA, a national organization of life sciences training professionals.
Note: Use coupon code NB5SQH8N and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.