Houston, TX, July 26, 2012 --(PR.com
)-- Why should you Attend:
Learn and understand the regulatory expectations for, and the proper design and maintenance of effective and compliant Standard Operating Procedures (SOPs).
Description of the topic:
The lack of or inadequate standard operating procedures (SOPs) continues to dominate the FDA's inspectional observations. In 2010, they accounted for over 10% of the total drug observations, lagging only behind the Quality Unit concerns. SOPs are often used as training tools and as such, 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 we've seen procedures being constantly revised. This leads to lengthy and expensive investigations and costly revisions. In this webinar you will 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 Session:
1. Why we need written procedures.
2. FDA’s expectations for an effective written documentation.
3. Regulatory requirements for the creation, compliance and maintenance of written procedures.
4. Proven techniques for creating effective SOPs and other written documents to minimize costly revisions.
5. Roles and responsibilities for the review and approval of written documents consistent with compliance requirements.
6. A system for training and implementation of written procedures.
7. Control, archival and disposal of written procedures.
Who will benefit: (Titles)
Technicians and general staff with the responsibility for creating, reviewing and approving written standard operating procedures and instructions
Henry Urbach is a Management Consultant, Founder and President of GMP TDC LLC, a training, development and consulting company that caters to pharmaceutical and biotechnology 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, quality systems, and aseptic and environmental monitoring techniques. Henry is a founder and President of GMP Training, Development and Consulting LLC (GMP TDC), a New York-based consulting organization serving Life Sciences industries. 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)