Guide to Writing and Maintaining Standard Operating Procedures (SOPs)

Why Should You Attend:
International standards require compliance with SOPs when developing, clinically evaluating and marketing medical devices. All regulated companies are required to have Standard Operating Procedures. The International Conference on Harmonization calls out many of the areas needing SOPs including device development, clinical trial planning, documentation, information storage, report writing, etc. Many medical device companies are still in transition to meet the new Medical Device Directive 2007/47/EC which suggests a need for additional clinical evaluations (even for Class I devices) and this session will review some standard clinical trial and clinical evaluation SOPs.

This session will go over the basics: What is an SOP, Why do we need SOPs, what are the risks involved if we do not have and/or do not follow our SOPs. We will review examples from warning letters and then explore some good SOP practices including a few templates for SOP development. This should be a good starting point for anyone needing to create a set of SOPs including clinical data evaluation.

Areas Covered in the seminar:

• What is an SOP?
• Why do we need SOPs?
• What are the risks involved if we do not have and/or do not follow our SOPs?
• Some examples from warning letters about the need for SOPs.
• How do I write an SOP?
• What is a template for SOP development?
• Where do I start if I need to create SOPs to conduct a clinical trial?

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to standardize their systems to ensure quality results, including companies in the Medical Device, Diagnostic, Pharmaceutical, Biologics and Food/Dietary Supplement fields. The employees who will benefit include:

• Clinical Research managers and personnel
• CRO specialists
• QA/RA managers and personnel
• Quality system auditors
• Consultants
• US FDA personnel

Instructor Profile:
Dr Joy Frestedt, is the President / CEO for Frestedt Incorporated (www.frestedt.com; 612-219-9982), a consulting group of over 50 experts providing services in the broad areas of clinical trial development and execution, as well as US and international regulatory compliance, medical writing and management of corporate quality systems. Dr. Frestedt has over 25 years experience running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and the development of quality systems to compete globally. Frestedt Incorporated is a novel virtual network of highly skilled staff meeting specific needs for large and small projects.