Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues.

Why should you attend:

Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. Worse, this often leads to many regulatory errors that first come to light during a FDA audit.

This webinar will show you how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

Areas Covered in the Session:

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP.  Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Areas Covered in the Session:

• SOPs and their relation to the regulations

• SOPs as part of the company's regulatory infrastructure

• SOP on SOPs and how to ensure conciseness, consistency and ease of use

• Risk Based approach on SOP Best Practices for creation and maintenance

• Training on SOPs

• Tools for SOP tracking and when is validation required

• What the FDA looks for in SOPs during an inspection

Who will benefit: 

• CEO
• Regulatory VP
• Quality VPs
• IT VPs
• Regulatory Affairs professionals
• Quality Managers
• Quality Engineers
• Small business owners GxP Consultants

Target Companies: 

Pharma e.g. Pfizer, Roche, GSK; Biotech e.g. Genentech; Medical Device e.g. Medtronic, Stryker; CROs e.g. Covance, Quintiles, Theorem etc.

Target Associations:

Pharma e.g. Pfizer, Roche, GSK; Biotech e.g. Genentech; Medical Device e.g. Medtronic, Stryker; CROs e.g. Covance, Quintiles, Theorem etc.

Target  Audience: 

Pharma, Biotech, Medical Device, Anyone involved with FDA