Attending this training will help the participants 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 the FDA's expectations. This can help mitigate risks, reduce errors, and ensure product quality and patient safety.
WHY SHOULD YOU ATTEND?
Formal and written Standard Operating Procedures (SOPs) are the foundation of good operations. SOP deficiencies are one of the top 5 audit findings by the FDA. Additionally, nearly every deficiency identified in FDA’s 483s, and Warning Letters can be traced back to organizations' lack of or deficient SOPs
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 in 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 its processes are complete, accurate, and followed consistently.
LEARNING OBJECTIVES
Attend the webinar to know why written procedures and beneficial and understand the FDA expectations for regulatory requirements and written documents.
WHO WILL BENEFIT?
The following professionals will benefit from this training:
- Managers
- Supervisors, and lead workers in Regulatory Affairs
- Quality Assurance and Quality Control personnel
- Quality systems specialists
- Document control specialists
- CAPA specialists and managers
- Regulatory and compliance specialists
- Internal auditors and managers
- Training specialists and managers
- Subject matter experts and process owners who write procedures
- CAPA Specialists
- Supplier Quality Engineers and Auditors
- Directors, Managers
- Technical writers and General staff with the responsibility for creating, reviewing, and approving written standard operating procedures and instructions
Formal and written Standard Operating Procedures (SOPs) are the foundation of good operations. SOP deficiencies are one of the top 5 audit findings by the FDA. Additionally, nearly every deficiency identified in FDA’s 483s, and Warning Letters can be traced back to organizations' lack of or deficient SOPs
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 in 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 its processes are complete, accurate, and followed consistently.
Attend the webinar to know why written procedures and beneficial and understand the FDA expectations for regulatory requirements and written documents.
The following professionals will benefit from this training:
- Managers
- Supervisors, and lead workers in Regulatory Affairs
- Quality Assurance and Quality Control personnel
- Quality systems specialists
- Document control specialists
- CAPA specialists and managers
- Regulatory and compliance specialists
- Internal auditors and managers
- Training specialists and managers
- Subject matter experts and process owners who write procedures
- CAPA Specialists
- Supplier Quality Engineers and Auditors
- Directors, Managers
- Technical writers and General staff with the responsibility for creating, reviewing, and approving written standard operating procedures and instructions
Speaker Profile
![ins_img](/Speaker_Pics/MeredithCrabtree.jpg)
Meredith Crabtree has over 25 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical devices, Cosmetics, Supplements, and Animal Health manufacturing and distribution. Meredith 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.
Upcoming Webinars
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Artificial Intelligence (AI), Machine Learning, and FDA Com…
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Female to Female Hostility @Workplace: All you Need to Know
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Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
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2024 EEOC & Employers: Investigating Claims of Harassment &…
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Transforming Anger And Conflict Into Collaborative Problem …
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Recruiting is Easy: Using a Sales and Marketing Approach
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How to Write Procedures to Avoid Human Errors
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Dynamic Presentations: Advanced Techniques with PowerPoint …
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FDA Regulation of Artificial Intelligence/ Machine Learning
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Behavioral Issues, Conflict and Incivility in The Workplace…
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Onboarding is Not Orientation: How to Improve Your New Hire…
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Effective Onboarding: How to Welcome, Engage, and Retain Ne…
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6-Hour Virtual Seminar on Learning the Highlights of Excel …
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Impact Assessments For Supplier Change Notices
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Developing an FDA/ISO Compliant Quality Management System
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Aligning Your HR Strategy with Your Business Strategy
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Accounting For Non Accountants : Debit, Credits And Financi…
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Dealing With Difficult People In Life & Work
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Managing Difficult Employee Conversations
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I-9 Audits: Strengthening Your Immigration Compliance Strat…
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Essential Job Functions According to the American with Disa…
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Pay Equity Changes for 2024! What Employers Need to Know to…
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Leader Branding: How to Communicate with Confidence to Attr…
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Why EBITDA Doesn't Spell Cash Flow and What Does
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Design Verification, Validation and Testing for Medical Dev…
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FFIEC BSA/AML Examination Manual: What Compliance Officers …
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Project Management for Non-Project Managers - How to commun…
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Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
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Harassment, Bullying, Gossip, Confrontational and Disruptiv…
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Employee or Independent Contractor – U.S DOL Announces 2024…
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Best Practices in Complaint Management for Regulatory Compl…
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Ensuring Safe and Effective Pharmaceutical Products: A Comp…
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Human Factors Usability Studies Following ISO 62366 and FDA…
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Tattoos, hijabs, piercings, and pink hair: The challenges …
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Gossip-Free: Leadership Techniques to Quell Office Chatter
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Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
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Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
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Understanding and Analyzing Financial Statements
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Divorce, Adoption and Other Special Tax Topics
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Setting up Quality System for FDA Regulated Products: Tips …
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Is Your Culture Working For or Against Your Success? If You…
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With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
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