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In pharmaceutical manufacturing, the analytical burden of testing every incoming batch of raw materials can be significant.
Join a free one-hour webinar on June 9 to learn how skip-lot testing can drive operational efficiency without compromising patient safety.
What is skip-lot testing?
Skip-lot Testing (also called periodic testing or skip-batch testing) is a risk-based approach, in which specific tests are performed on pre-selected batches and/or predetermined intervals, rather than on a batch-to-batch basis, with the understanding that those batches not tested must still meet all the acceptance criteria established for that material. It is typically applied to low-risk materials with long history of compliance.
This approach is permitted by the regulatory guidance – including ICH Q7 and FDA 21CFR Part 211.84 – when supported by robust supplier qualification, demonstrated process capability, and ongoing monitoring though trend analysis.
What attendees will learn
· Regulatory and technical requirements for implementing your skip-lot testing program
· Best practices for QA teams
· Real-world examples of skip-lot testing programs
Speakers
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 The webinar will be hosted by Sergio Hernandez and Sheila Puspasari. Sergio is an industry veteran with more than 30 years experience with companies including Ashland, Shin-Etsu and Farma International.
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 Sheila is a pharmaceutical professional with more than a decade of international experience in the life science industry. She received the prestigious Fulbright scholarship to support her studies at North Carolina State University, where she earned her Master’s degree in Biomanufacturing. She worked as technical manager at both Colorcon and GSK before taking up her current role as DFE Pharma's technical manager of North America. |
Why Attend Live?
Whether you’re leading a QA, technical or procurement team, this webinar will give you actionable insights to launch your own skip-lot testing program. Attendees will have the opportunity to participate in a live Q&A session and receive exclusive post-webinar resources.
To encourage candid conversation, operational examples or challenges shared by attendees will be discussed in a way that remains anonymous and not attributable to your company.
Join us:
June 9, 1-2 p.m. EDT English-language session, 3-4 p.m. EDT Spanish-language session
Closed captioning will be offered in English, Spanish, Portuguese, and French.
Register to participate! Seating is limited.
FAQ
Is the webinar free?
Yes, the skip-lot testing webinar is free to all attendees.
How long is the webinar?
The webinar is one hour with 40 minutes for the presentation and 15-20 minutes for live audience questions.
Who should attend?
This webinar is for quality, technical and procurement teams.
What platform will the webinar use?
The webinar will be hosted on Teams. Registered attendees will received access to details by email.
How long will the Q&A last?
We’ve reserved 15-20 minutes at the conclusion of the session for live audience questions.
Will a recording be available?
Yes, all registered attendees will have access to the webinar recording after the event.
How do I register to attend?
Complete the short form linked here: Register for the skip-lot testing webinar!