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ComplianceOnline, Online Event
2013-01-18
Why Should You Attend:
This webinar will provide the basic building blocks (and beyond) that you will need to develop & maintain your company’s formal standard operating procedures program. The webinar will show how sops can be developed and implemented, even if the program is started from scratch. The course will also demonstrate the formal approval process and distribution methods.
The webinar will also focus on the following components of sops.
- Why standard operating procedures need to be in written format.
- The required parts of an SOP to meet FDA compendia regulatory requirements.
- How to write an effective SOP.
- The mechanics of sop documentation maintenance, distribution, filing, revisions, and retention methodologies.
Learning Objective:
Participants will learn how to effectively write, maintain, file, review, and revise SOP within the organization.
Areas covered in this Seminar:
- How the SOP template is developed.
- What are the component parts of an SOP – component parts are explained.
- The development of an effective SOP numbering system.
- The mechanics of the SOP – how the sop is written.
- What is needed in the SOP for the inclusion/reference of forms and reports applicable to the SOP.
- Detailed explanation of the SOP document approval process and its specific mechanics.
- How to distribution SOP s and what are the retention requirements.
- SOP annual review process explained.
- How to handle obsolete SOPs.
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Organized by:
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Complianceonline |
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Invited Speakers:
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Gary D. Kimmel, President and Consultant, of Quality Management Systems & Design Company has 30 years of continuous industry experience in pharmaceuticals, medical devices, foods, and cosmetics. His passion for “doing it right the first time” has led Mr. Kimmel into continuous leading roles in the quality assurance field. He has performed and led internal and external quality assurance audits for both domestic and international compliance of both the FDA and DEA regulations.
Mr. Kimmel is a noted expert in both Operations/QA cGMP training and mentoring; writing, designing, and implementing complex SOPs and documentation control systems; variance and CAPA services from coding, investigations, through final resolution; and process mapping/efficiency controls for both QA/Operations to reduce bottlenecks in processes. Mr. Kimmel has also designed and implemented operational and quality assurance systems for start-up companies.
In his spare time, Mr. Kimmel enjoys woodworking, has been involved in historic theater restorations/preservation, and set construction for shows presented year round. His greatest reward in set construction comes from training and mentoring new volunteers to work with power equipment and hand tools; accompanied by learning the principles of set construction theory and mechanics.
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Deadline for Abstracts:
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2013-01-17
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Registration:
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http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702689?channel=Hummolgen
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E-mail:
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referral@complianceonline.com
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