Writing Effective sops for FDA and CLIA Regulated Companies

Date: August 16, 2024

Time: 1 PM EST

Duration: 60 Mins.

Level: Intermediate to Advanced

Group Packages: Please contact ben@complyrules.com

Description

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 42. 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 seemingly impossible. This often leads to regulatory errors that come to light during a FDA audit. Every FDA and CLIA inspection start with a review of SOPs. Thirty to forty percent (30%-40%) of adverse inspection issues are a result of poorly written SOPs.

Course Objective

This course 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. You will also gain a strategic view of how SOPs help streamline operations and create efficiencies, while ensuring regulatory compliance. This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow.

Course Outline

• SOPs and their relation to the regulations
• SOPs as part of the company's regulatory infrastructure
• Best Practices for writing SOPs to ensure conciseness, efficiency and ease of use Risk Based approach for writing SOPs
• Training on SOPs
• Tools for tracking SOPs life-cycle and when validation is required
• What an inspector looks for in SOPs during an inspection

Target Audience

• CEOs
• Regulatory VPs / Quality VPs / IT VPs
• Regulatory Affairs Professionals
• Quality Managers
• Quality Engineers
• Small Business Owners
• GxP Personnel
• Consultants

Additional service: (Personalized session)

We also do various similar customized events for our clients and it is specially tailored as per the client's requirement. We arrange calls between clients and our course instructors to better understand the training requirement and accordingly a training program is designed. The course duration ranges between 90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3 days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation, Clinical compliance, and almost everything that falls under Risk, Quality and Compliance arena in the Life Science industry.

If you think that your team needs some kind of boost, update or refresher in Risk management and Regulatory compliance then let me know and we can design a highly cost efficient program for you.