A Systematic Approach To Writing Effective and Compliant SOPs

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With increasing competition and consumer demand, pharmaceutical, biotech. and medical device manufacturers are becoming more patient-focused.

Almost overnight, organizations have made substantial changes in their approach to research, clinical trials, manufacturing, supply chain, cybersecurity, data privacy and patient engagements.

Regulators across the world have started multiple initiatives to get lower-cost drugs and devices to market, and to streamline and accelerate the research and development process.

But, how do you manage the complex web of regulatory obligations governing your business? How do FDA-regulated companies implement the processes and policies to sustain compliance?

Developing Standard Operating Procedures (SOPs) which are required for companies that are regulated is a good place to begin to manage the web of regulatory obligations.

However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit.

Technically, all FDA inspections include an SOP review and it is very important to have them designed such that they are easy to maintain and update.

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.

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance.

For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations.

CoursWorx through its affiliate partner is offering a webinar where you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.

To accomplish these goals, we will review regulatory agency expectations when an SOP is written, provide suggestions for uncovering the process in its entirety and describe it clearly and concisely, indicate how to break portions of the process(es) into logical chunks, and show how the SOP and the training program can work together harmoniously.

Understanding how the average employee is swamped with more work than they can manage, we will also provide tips for shortening this process and take advantage of tools that probably already exist in the systems that you use on a day-to-day basis.

We will provide valuable insights and examples that reflect the extensive experience of the instructor in the documentation and training fields., and which can assist you in writing and implementing SOPs with maximum efficiency and effectiveness.

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.

The webinar will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

The webinar instructor will offer guidance on how to get from regulations to the SOP.

Finally, you’ll learn best practices for creating, implementing and maintaining SOPs using a risk-based approach and best practices for getting SOPs ready for inspection will be presented.

To find out more about this webinar and how this will help you develop “A Systematic Approach To Writing Effective and Compliant SOPs“, Click this link RIGHT NOW!”



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About CoursWorx

CoursWorx provides resources for Life Science professionals working in the field of Validation and Regulatory Compliance. 

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