How to Write SOPs: Tips on Writing the Perfect Document to Impress the FDA

Why Should You Attend:

Formal and written Standard Operating Procedures (SOPs) are the keystone of good operations. SOPs create an important evidence and documentation for the regulatory compliance status of an organization and are one of the first things auditors wants to review when inspecting a site.

Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at the given organization. SOPs are often poorly written, communicated, monitored and enforced.

Attend this webinar to learn what exactly an SOP should contain, what should be its format and tone, who should write it, when and how should it be revised or retired, how many SOPs should be there, what activities do not need SOPs, how should SOP training be conducted and documented, and many other issues impacting the compliance with FDA requirements from SOPs.

You will learn how to take your current SOPs to a level that not only would demonstrate your expertise about your operations but also make it easier for your personnel to follow.

Areas Covered in the Seminar:

This seminar will provide easy-to-master techniques to prepare perfect SOPs. Topics covered include

• Essential elements of an SOP.
• Process mapping techniques to define the contents of an SOP.
• Role of personnel in creating SOPs.
• SOP revisions, updates, creating, retirement, and documentation.
• Categorization of SOPs.
• Assessment of compliance techniques.
• Training practices for FDA compliance.
• Access and access control to SOPs.

Learning Objectives:

Learning how create perfect, easy to follow, and highly FDA compliant SOPs in less than an hour

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• QA/QC/Compliance/Regulatory affairs professionals
• Senior management executives (CEO, COO, CFO, etc)
• Manufacturing managers, supervisors & personnel
• Clinical and preclinical laboratory managers
• Clinical trial specialists
• Project Managers
• People investing in FDA-regulated product development projects

Instructor Profile:

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( www.amarexcro.com ). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

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