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 …
How to Write Contracts for Procurement Professionals
How to Deal with Employees Who Love to Argue and Debate Eve…
Project Management for administrative professionals
Sunshine Act Reporting - Clarification for Clinical Research
Onboarding Best Practices for 2025: Proven Strategies to Po…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Reprogramming your mind for Corporate Excellence: 4 Steps t…
Terminating Toxicity: Strategies For Leaders To Confidently…
ChatGPT and Project Management: Leveraging AI for Project M…
Uplifting the Credibility of HR: How to Build the Credibili…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
How to Write Effective Audit Observations: The Principles f…
Strategic Interviewing & Selection: Getting the Right Talen…
Onboarding Best Practices for Millennial and All Employees
Performance of Root Cause Analysis, CAPA, and Effectiveness…
Bridging Generational Divides in the Workplace
Emotional Intelligence: Mastering the Emotions of Great Lea…
FDA Audit Best Practices - Do's and Don'ts
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Accounting For Non Accountants : Debit, Credits And Financi…
Successful Strategies for FDA Expedited Pathways for Your D…
Regulation update Q1 2025: New and Proposed Regulations for…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Pay Transparency in Action: Strategies for Building Trust a…
Designing Employee Experiences to Build a Culture of Compli…
Reinvent Your Business with the Power of AI
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …
Developing and Implementing Quality Culture in the Organiza…
Tips and Techniques for Conducting an Effective Fraud Risk …
Break Free from Toxicity: Reclaim Your Power and Peace
Physician Employment Agreements: Problem Areas that can be …
Measure the Effectiveness of Compliance Programs by Engagin…
FDA Regulation of Artificial Intelligence/ Machine Learning
Quality Management Systems and Data Integrity
Implementing an Effective Human Error Reduction Program
Navigating 2025 Employment Laws: What Every Employer Needs …
Cleaning Data without Complex Functions - A Course for Data…
Succession Plan for 2025: It's Not Just for Emergencies - I…
Employers Should Prepare for Immigration Raids in 2025! Thi…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Using High-Performance Coaching for Managers to Address Per…