Writing and enforcing effective sops
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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.

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Writing and Enforcing Effective SOPs

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Writing and enforcing effective sops

Writing and Enforcing Effective SOPs

Speaker: David R. Dills| Date: 11th October 2016 2016 2016 | 10:00 AM PST | 01:00 PM EST

Contact Us : Email: [email protected] | Tel: +1-248-233-2049


Description

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.

Description:


Areas covered in the session

  • The SOP end user, required sections and best practices for SOP development

  • Tips that help and work when you need to create, clear, concise procedures

  • Improve your writing skills

  • Development and formatting recommendations: Content and Structure

  • Reminders that you need to know when you critique your own procedures

  • FDA and overall global expectations and requirements for SOP development, implementation and enforcement

  • Create SOPs for the target audience

  • Provide appropriate level of details and use writing conventions

  • Have increased confidence in planning and writing your SOPs

Areas Covered in the Session:


Who will benefit

  • Regulatory Affairs

  • Clinical Affairs

  • Quality Assurance/Quality Control

  • Compliance

  • Marketing & Sales

  • Manufacturing and Technical Services

  • Engineering

  • IT/MIS

  • Executive Management

Who will benefit:


Instructor profile

David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, cosmetics and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience 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 and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits.  

Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.

Instructor Profile :


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