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SOPs- How to Write Them to Satisfy Inspectors
- Overview of the importance of SOPs in FDA-regulated industries
- Overview of FDA regulations applicable to SOPs (e.g., 21 CFR Part 211, 21 CFR Part 820)
- Key elements and requirements for SOPs according to FDA expectations
- Appropriate Outline and Format of SOPs
- Appropriate use of terminology
- Identify the audience.
- Use of Process Maps, Pictures, Diagrams, If/ Then charts, etc.
- Common Deficiencies and Pitfalls
- How to Mistake proof SOPs through use of Industry Best Practices and Agency expectations
- General Overview of Document Control and how to put it into practice.
- FDA expectations on SOP training
Overview of the webinar
The FDA and most other regulatory agencies require formal written procedures. Your SOPs are likely the first thing an FDA investigator will ask for when they arrive at your facility. Did you know that SOP deficiencies are one of the top 5 findings in FDA audits? These deficiencies can compromise or cause failures to an organization’s entire Quality Management System, often leading to other FDA observations, product recalls or even worse, Warning Letters. This training will describe common mistakes and best practices to help any organization communicate that their processes are complete, accurate and followed consistently.
Unlock the keys to regulatory success with “SOPs- How write them to satisfy inspectors." In the world of FDA-regulated industries, Standard Operating Procedures (SOPs) are the foundation upon which compliance and operational excellence stand. Join us for an immersive experience that goes beyond conventional training, providing professionals with the insights, best practices, and practical skills needed to navigate the complexities of SOP development, implementation, and maintenance.
This training is strategically crafted to address the critical role that SOPs play in regulatory compliance. SOP deficiencies consistently rank among the top findings in FDA audits, posing significant risks to an organization's Quality Management System (QMS) and potentially leading to severe consequences. Our training aims to empower professionals with the knowledge to not only avoid common pitfalls but also to elevate SOPs as strategic tools for ensuring completeness, accuracy, and consistent adherence to regulatory standards.
Who should attend?
Quality Assurance (QA) Department:
- QA Managers
- QA Specialists
- QA Analysts
Regulatory Affairs Department:
- Regulatory Affairs Managers
- Regulatory Affairs Specialists
- Compliance Officers
Manufacturing and Production Department:
- Manufacturing Managers
- Production Managers
- Operations Managers
Research and Development (R&D) Department:
- R&D Managers
- R&D Scientists
- Product Development Specialists
Clinical Research Department:
- Clinical Research Managers
- Clinical Research Associates
- Clinical Trial Coordinators
Validation Department:
- Validation Managers
- Validation Engineers
- Validation Coordinators
Quality Control (QC) Department:
- QC Managers
- QC Analysts
- QC Technicians
Compliance Department:
- Compliance Managers
- Compliance Specialists
- Regulatory Compliance Officers
Medical Affairs Department:
- Medical Affairs Managers
- Medical Writers
- Medical Information Specialists
Laboratory Department:
- Laboratory Managers
- Laboratory Technicians
- Analytical Chemists
Risk Management Department:
- Risk Managers
- Risk Analysts
- Patient Safety Officers
Supply Chain and Logistics Department:
- Supply Chain Managers
- Logistics Managers
- Distribution Specialists
Clinical Operations Department:
- Clinical Operations Managers
- Clinical Operations Specialists
- Study Coordinators
Complaint Handling and CAPA Teams:
- Complaint Handling Managers
- CAPA Coordinators
- Corrective and Preventive Action Teams
Pharmacovigilance Department:
- Pharmacovigilance Managers
- Drug Safety Specialists
- Adverse Event Coordinators
Infection Control Department:
- Infection Control Managers
- Infection Preventionists
- Healthcare Epidemiologists
Auditing and Inspection Department:
- Internal Auditors
- External Auditors
- FDA Inspectors
Health and Safety Department:
- Health and Safety Managers
- Occupational Health Specialists
- Environmental Health Officers
Documentation and Recordkeeping Department:
- Document Control Managers
- Records Management Specialists
- Document Compliance Officers
Why should you attend?
Attending this training will help the participant understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance. By learning how to write SOPs that satisfy FDA inspectors, participants can proactively identify and address potential compliance gaps or issues. This training will provide them with the knowledge and skills necessary to develop robust and comprehensive SOPs, minimizing the risk of regulatory non-compliance and associated penalties.
Effective SOPs not only satisfy FDA inspectors but also contribute to improved operational efficiency and consistency within an organization. By attending this training, one will learn how to write SOPs that clearly outline procedures, roles, and responsibilities, promoting standardized processes and reducing variability in operations.
Well-written SOPs provide clear instructions on how to perform tasks correctly and safely. By attending this training, participants will gain insights into developing SOPs that prioritize quality and safety, aligning with FDA's expectations. This can help mitigate risks, reduce errors, and ensure product quality and patient safety.
Faculty - Miss.Meredith Crabtree
Meredith Crabtree has over 25 years’ experience in regulated industries ranging from Pharma, Medical Device, Biologics, Laboratory testing, Cosmetics, and Supplements. She has worked in both manufacturing and distribution as well as Human Health and Animal Health. Meredith currently works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality training. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.