2-day In-person Seminar on “Writing and Enforcing Effective SOPs” at Minneapolis

Overview:

Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. 

This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. 

Who Will Benefit:

• Regulatory Affairs
• Clinical Affairs
• Quality Assurance/Quality Control
• Compliance
• Marketing & Sales
• Manufacturing and Technical Services
• Engineering
• IT/MIS
• Executive Management
• Laboratory Operations
• Customer Service
• Clinical Research managers and personnel
• Specialists/SMEs in all departments
• QA/RA managers and personnel
• Quality System auditors
• Distributors/Authorized Representatives
• Legal Counsel
• Consultants

Speaker Profile:

David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.

DATE, VENUE & PRICE:

Location: Minneapolis, MN| Sep 26^th & 27th, 2013 | 9 AM to 6 PM PDT
Venue: WILL BE ANNOUNCED SOON

Price: $1295.00

Contact Information:
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