2017 - Webinar on Effective Standard Operating Procedure (SOPs) Development for Regulatory Compliance

Description:
The FDA and other world health authorities require industries to submit Standard Operating Procedures (SOPs). However, at present, there exists no guide on how to develop or manage SOP creation, or regarding the SOP quality system. Because of that, SOPs are often written in a way that makes compliance really difficult. In this webinar, our speaker will discuss SOPs, and take you through the process of writing effective documents. You will also learn how to write, organize and maintain SOPs. The speaker will also provide guides on how to train personnel to ensure compliance, in an easy way.
You will learn and understand about written procedures, and why they are beneficial. Our speaker will also cover important subjects such as FDA expectations for written documents and regulatory requirements, implementation of a training program for creating and reviewing documents, development of a system for controlling, archiving and disposing of written proposals, and development of an effective review and approval process, which complies with regulatory requirements.
Learn how to meet their expectations and fulfill their requirements, so your documents are approved quickly, and there are no complications or problems. For preparing the documents, you need to know how to format SOPs, what elements to include in them, and how to write effective and efficient documents. You also need to know the roles and responsibilities of SOP authors and reviewers, and how to define roles in SOPs.
Areas Covered in the Session :
SOPs and their relation to the regulations
Why written procedures are beneficial
FDA expectations for written documents and Regulatory Requirements
Developing an effective review and approval process compliant with regulatory requirements
How to implement a training program for document creation and review
A system for the control, archival, and disposal of written procedures
Formatting SOPs
Elements to include other than the procedure
How to write effective but efficient documents
Roles and responsibilities of authors and reviewers of SOPs
How to define roles in SOPs for supervisors and operators
Who Will Benefit:
Quality Managers
Quality Engineers
Production Teams
Research and Development Teams
Compliance Teams
Documentation Teams
GxP
Regulatory Affairs Teams
Consultants
Small Business Owners