Date: 7th - 21st July, 2008

Location: web seminar, USA

Summary:
Clinical, Cosmetic, Pharmaceutical, Water - Seminar

The development and use of Standard Operating Procedures (SOPs) are an integral part of a successful quality system, providing individuals with the information to perform a job properly, as well as facilitating consistency in the quality and integrity of a product or end-result.

Pharmaceutical manufacturing has an obligation to regulatory agencies and good manufacturing practice regulations. Therefore, each site must have appropriate SOPs in place in order to ensure consistent processes that meet or exceed regulatory expectations.

SOPs detail the regularly recurring work activities that are to be conducted or followed within an organization to ensure consistent conformance to technical and quality system requirements, as well as regulatory obligations. Poorly written SOPs are of limited value. In addition, the best written SOPs will fail if they are not followed. To ensure continuous success, the use of SOPs needs to be reviewed, revived and re-enforced by management.

This 3-session live web seminar series will serve as an ideal complement to a company's training program, examining the fundamental aspects of an effective and efficient SOP system, from the design and format to the training and control of SOPs. Sessions will be held two weeks apart to allow participants to evaluate their company's position with regards to the information obtained during each session.

Discussion Points will include:
Importance and purpose of SOPs
FDA and EU expectations
SOP design and format
Mapping, developing and writing the SOP
SOP approval and authorizing
The Use of SOPs
The review and revision process
Document control
Training personnel on SOPs

Learning Benefits of 3-Session Series:
Answers to:

• Why have and use procedures? What makes an effective SOP?
  
• Review the regulatory requirements and expectations for procedures
  
• How to collect information that should be used in a procedure
  
• Identify why some SOPs are difficult to understand, use and are not readily accepted by the users
  
• Examine the difficulties in writing and using procedures
  
• Discuss different formats, sections and styles for procedures
  
• Distinguish between SOPs, guidelines, policy statements and work instructions
  
• Implement appropriate SOP training programs
  
• Integrate SOPs into a comprehensive document management system
  
• Top Ten reasons for writing SOPs