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.
HIPAA Compliance in 2026 — Practical Strategies for Breach …
Launch Your Career: The Ultimate Guide for Emerging Profess…
Moving From an Operational Manager to a Strategic Leader
Discover how Emotional Intelligence turns AI from a technic…
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Empowering Conflict Resolution: Letting Go to Gain Control
The 60 Minutes Introduction to DAX
The 6 Most Common Problems in FDA Software Validation and V…
High-Impact Performance Management: Tools, Tactics & Coachi…
AI Across the Business: Practical Use Cases for Founders an…
Faster, Better Talent Acquisition: Leveraging AI & ChatGPT …
The Anti-Kickback Statute: Enforcement and Recent Updates
Do's and Don'ts of Giving Effective Feedback for Performanc…
Emotional Intelligence: Mastering the Emotions of Great Lea…
Copilot and HR: An Introduction for HR Professionals
Goal Mastery: From Resolutions to Results in 2026
Your AI Advantage: How HR Professionals Can Use Claude to S…
Human Error Reduction Techniques for Floor Supervisors
Validation of FDA-Regulated Medical Device and SaMD Product…
Human Factors Usability Studies Following ISO 62366 and FDA…
Managing Toxic & Other Employees Who Have Attitude Issues
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…
Major cGMP Issues: FDA Concerns in 2026
4-Hour Virtual Seminar on Transformational Leadership - The…
Understanding EBITDA – Definition, Formula & Calculation
DOL Reverses Course on Independent Contractor Rule for 2026…
Managing Toxic Employees: Strategies For Leaders To Effecti…
ChatGPT and Project Management: Leveraging AI for Project M…
Navigating HR Like A Pro: What Every Small Business & New H…
HPLC Analytical Method Development and Validation
Negotiating Skills For Professional Results - Winning Strat…
Managing Projects When AI Joins the Team: Human Judgment, A…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Paying and Receiving Payments for Referrals: You Can Go to …
Ten Red Flags that Signal Financial Distress in Business Cu…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Fatal Errors Employers Make When Updating Employee Handbook…
AI Fundamentals for All Leaders and Managers: How to Work S…