Validation of aseptic processes is essential to ensuring the successful end result for manufacturers – a safe, effective finished product. However, the process starts long before that. Active ingredients and sterile bulk material must achieve the appropriate level of sterility assurance. This course will provide an in-depth overview of the requirements for cGMP-compliant aseptic process validation. This includes a detailed summary and analysis of mandates and guidance from several entities, including the US Food and Drug Administration (FDA), the Pharmaceutical Inspection Co-operation Scheme (PICs), and the European Union (EU). This interactive session will highlight industry best practices, and discuss common errors and deficiencies.
Finally, this course will discuss prospective, concurrent, and retrospective validation, plus the role of revalidation.
At the completion of this course, attendees will be able to:
Operations employees participating in manufacturing, quality control testing, and validation as part of their job function will find this course highly beneficial. This includes employees in the following functions:
At the completion of this course, attendees will be able to:
Operations employees participating in manufacturing, quality control testing, and validation as part of their job function will find this course highly beneficial. This includes employees in the following functions:
Kelly Thomas
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
FDA Compliance and Clinical Trial Computer System Validation
From Awareness to Action: Going Beyond the Law in Preventin…
5 Proven Ways To Engage & Retain Your Team Even During The …
Form 1099 Update 2023: Latest Forms, Rules and Reporting Re…
Customer Relationship Management: Strategic Methods to Mana…
Strategic Interviewing & Selection: Getting the Right Talen…
Navigating New Paths: Unveiling Your Unique Abilities for a…
Amazing (!) AI Tools For Building Your Business
Implementing a Robust Change Control Program - Key Elements…
Project Management for Non-Project Managers - How to Effect…
Excel - Unleashing the Full Potential of New Functions (Exc…
How to Conduct Annual Product Reviews to Achieve GMP Compli…
Onboarding is NOT Orientation - How to Improve the New Empl…
Time Management/Four Functions of Management
Responding to EEOC Discrimination Charges-What's Your Busin…
What Business Leaders Need to Know About Cybersecurity Prep…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Motivation - Motivating Yourself & Others
Understanding Social Security and Optimizing Retirement Inc…
Excel - Power Pivot and The Data Model - Building Advanced …
Stop Letting that Difficult Person Ruin your Day - Effectiv…
2023 ADA Accommodation Compliance Requirements
Fight Inflation by Optimizing Working Capital with Advanced…
Performance of Root Cause Analysis, CAPA, and Effectiveness…
Winning Conversations: How to Communicate Successfully and …
Human Connection Leadership in 3D: Dare. Dream. Deliver.
Employee Handbook Requirements for 2023. Includes Updated F…