Aseptic processing deficiencies are one of the most cited observations in FDA 483s and warning letters. Since regional regulatory bodies each have their own requirements, staying compliant can be a confusing and complex challenge. Simple planning and implementing best practices in accordance with a variety of cGMP guidances can help ensure that your organization is prepared for an audit.
If you and your colleagues are interested in learning how to build an aseptic training program that will produce quality product and withstand regulatory inspection, then join us for this live 90-minute session:
If you and your colleagues are interested in learning how to build an aseptic training program that will produce quality product and withstand regulatory inspection, then join us for this live 90-minute session:
Aseptic Processing: Preparing Staff and Programs For Compliance
Date: Thursday, April 7, 2016Time: 1pm EDT
Duration: 90 Minutes
Price: $299 – Includes Reference Documents
Course Description:
Producing high quality product requires effective fill/finish processes, solid aseptic techniques, detailed procedures, and well-qualified personnel who understand the impact of their actions on the product, process and environment. This course will give you the tools to understand the areas of concern, why they are so often cited, and tools to build an aseptic training program that will produce quality product and withstand regulatory inspection.
This 90-minute course will teach you how to:
- Identify threats to product sterility by understanding the typical issues FDA & EU inspectors find – and cite
- Assess your own process for effective practices
- Implement aseptic processing training programs that will withstand any level of regulatory scrutiny
Your Expert Instructor: Joanna Gallant
Joanna Gallant is an experienced, solutions-driven Quality professional with over 20 years of technical and operational experience within pharmaceutical, biotechnology and medical device manufacturing environments. She is one of the founders of and an instructor in the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine's Biotechnology degree program in 2011.
Reserve Your Seat or read the full course description here.
Reserve Your Seat or read the full course description here.
If you have any questions about the course, feel free to contact us.
Life Science Training Institute (LSTI) | 101 Gibraltar Rd., Ste. 100 | Horsham, PA 19044 |info@
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