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
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
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
So, You’re Now the “Boss”: Essential Skills to Succeed as a…
FDA Compliance And Laboratory Computer System Validation
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Managing Toxic & Other Employees Who Have Attitude Issues
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Managing Complex Projects - Project Management
Tips and Techniques for Conducting an Effective Fraud Risk …
Design Verification, Validation and Testing for Medical Dev…
21 CFR Part 820 - Quality System Regulation - Applying Prin…
Performance Management: Dealing With The Difficult Employee
Treasury Risk Management, Funding, Liquidity, Interest Rate…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Future-Proof Your Workforce: Mastering Succession Planning …
California Meal and Rest Breaks: What You Don't Know Can Co…
HIPAA Bootcamp for Health Care Providers, Professionals, an…
Essential Job Functions According to the American with Disa…
Improving Employee Engagement & Retention Through Stay Inte…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Dealing With Difficult People In Life & Work
Introduction to Generative AI for Accountants
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
3-Hour Virtual Seminar on Excel Deep Dive: Advanced Tips & …
Impact Assessment and Risk Management for Change Control
How to Write Effective Audit Observations: The Principles f…
Surviving and Thriving Organizational Change and Loss: The …
Marijuana: Compliance and Safety in the Workplace
Coming Soon - New Minimum Salary Levels for Exempt Employee…
FDA Regulation of Artificial Intelligence/ Machine Learning
Stressed Out: How to Handle Conflict, Difficult People and …
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud,…
2025 Top Employment Regulations That Will Impact Employers!
How to Handle Workplace Conversations Around Politics and R…
Why EBITDA Doesn't Spell Cash Flow and What Does
How to Give Corrective Feedback: The CARE Model - Eliminati…
SOPs - How to Write Them to Satisfy those Inspectors
Documenting Misconduct that Will Stand Up in Court
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Marketing to Medicare or Medicaid Beneficiaries - What You …
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Project Management for Non-Project Managers - How to commun…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Human Error Reduction Techniques for Floor Supervisors
Onboarding is NOT Orientation - How to Improve the New Empl…
Building GMP Excellence: A Guide to Implementing Compliant …