Seminar on Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

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.

Who Will Benefit:

This Seminar will provide valuable assistance and guidance to pharmaceutical, medical device and biotechnology manufacturers and other firms in the life sciences industry who require a refresher session on writing and enforcing their own SOPs and internal procedures or for those new to this area who desire to gain a better understanding of the SOP process.

The employees who will benefit include basically anyone and everyone at your organization who are required to write and/or comply with SOPs, including all levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the SOP process from start to finish, including:

• 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