Companies can prepare and train their staffs effectively for prior inspection management, but once the audit begins, certain difficult situations, requests or issues may arise that may prove hard to manage properly. In this webinar, you will hear about real life examples of inspection issues on different topics such as Opening Day, Documentation, Tours, SME situations, Safety, and Inspection team situations. We will examine what went right and how the situation may have been handled differently.
Every year or so, companies are visited by the FDA and other regulators to determine if they are properly complying with regulations.Once the inspectors arrive, there may be times that situations arise that are difficult to respond to. In this webinar, we will analyze how certain situations were handled and how they could have been handled differently, or what was positive about how they were handled.
Every year or so, companies are visited by the FDA and other regulators to determine if they are properly complying with regulations.Once the inspectors arrive, there may be times that situations arise that are difficult to respond to. In this webinar, we will analyze how certain situations were handled and how they could have been handled differently, or what was positive about how they were handled.
Danielle DeLucy
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she …
Excel - Reporting Simplified - Learn Pivot Tables from Scra…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Retention Starts Here: Stop Losing Your Critical Talent and…
Turning Workplace Conflict into Positive Connection
Project Management for Non-Project Managers - How to commun…
AI and Human Resources: The Great Opportunity!
The Business Case for LGBTQIA+ Inclusion in the Workplace: …
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
AI and Change Management - How to Lead with Confidence and …
Cyber Security Incident Response Team Training Program
Transforming Anger And Conflict Into Collaborative Problem …
Employee Handbooks: 2025 Critical Issues
Excel Power Skills: Master Functions, Formulas, and Macros …
The Courage to Speak: Overcoming Fear and Owning the Room
Finance & Accounting 101 Simplified
6-Hour Virtual Seminar on Learning the Highlights of Excel …
6-Hour Virtual Boot Camp on Microsoft Power BI
Developing an Agile Workforce with Emotional Intelligence (…
Compliance Under Fire: Navigating I9 Immigration Raids & …
Empowering Conflict Resolution: Letting Go to Gain Control
FDA Regulation of Artificial Intelligence/ Machine Learning
Human Error Reduction Techniques for Floor Supervisors
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
How To Conduct An Internal Harassment And Bullying Investig…
Leadership: Strategic Planning and Decision Making
Secrets Of Psychology - Why People Do The Things They Do
FDA Compliance And Laboratory Computer System Validation
Marketing to Medicare or Medicaid Beneficiaries - What You …
Polish your Presence on Linkedin - The Powerful Profile
Bootcamp for New Managers and Supervisors: Develop These Es…
Utilizing A Proven Process When Conducting Sensitive, Inter…
Leveraging Artificial Intelligence in HR
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…