subject: 10 Steps To Perfect Sops: Fda Acceptable Sops Made Easy [print this page] Description: Description:
Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDAs 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This seminar will provide step by step instructions to create SOPs for FDA-regulated organizations.
The author will discuss case studies and examples to highlight the common errors and potential solutions. Additionally, the logistics of creating, maintaining, scope, training and documentation will be reviewed. Pros and Cons of paper and electronic SOPs will also be discussed. This seminar contains a collection of practical tips from the trainers extensive FDA audit experience.
Why Should you Attend:
This seminar will help you evaluate your current SOPs for the presence of most common issues identified by FDA during audits. You will get practical tips and tested strategies for creating, revising, updating, training, and documenting SOP processes at your organization. The case studies will highlight the key concepts, alternate methods, and least-burdensome approach to compliance with FDA regulations.
Objectives of the Presentation:
Upon the webinar's conclusion, you should understand:
Essential elements of an SOP
Process mapping techniques to define the contents of an SOP
Role of personnel in creating SOPs
SOP revisions, updates, creation, retirement and documentation
Categorization of SOPs
Assessment of compliance techniques
Training practices for FDA compliance
Access and access control to SOPs.
Who can Benefit:
QA/QC/Compliance/Regulatory Professionals
Senior Management Executives (CEO, COO, CFO, etc)
Manufacturing Managers, Supervisors and Personnel>
Clinical and Preclinical Laboratory Managers
Clinical Trial Specialists
Project Managers
People Investing in FDA-Regulated product development projects.
