2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

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

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

$599

Recorded video

Recorded video session

$349

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Speaker: A.B,

Speaker has 40 years of experience working in hospitals and the Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Speaker is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. Speaker is co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley's Business School for Executive Education in Life Sciences and is now on the Stanford Who's Who Registry for contributions to the Lifesciences industry. She is also assisting the FDA with updating their guidance "General Principles of Software Validation" (published in 2002)