Successful process performance qualification (PPQ) and commercial launch requires planning well before manufacturing registration batches. This webinar is the first of a 2-part series. The series will focus on the recommended studies from a technical transfer group perspective that should be conducted pre-product registration and post registration to ensure a reproducible and scalable manufacturing process during PPQ and commercial launch.
This first part of the webinar series will focus on studies for pre-registration activities. Registration manufacturing is critical to a product’s regulatory filing, creating the proposed process for commercial manufacturing. While some changes can be made to the process post-registration, the level of change and subsequent studies (both engineering and clinical) can be costly and severely impact the timeline to launch a product. Through the use of risk-mitigation techniques and understanding regulatory requirements upfront, critical studies can be identified prior to registration manufacture that will de-risk the scale-up process.
Do you have questions about process performance qualification or tech transfer in general? Are you wondering what steps you need to take to ensure successful registration manufacture and commercial launch?
Join this engaging webinar as the presenters explore these issues and provide examples and information from years of real-world experience in pre-registration manufacture.
Speakers
Harry G. Cocolas, PhD., Senior Director of Technical Services, Mayne Pharma
As senior director of Technical Services for Mayne Pharma US, Harry is responsible for overseeing all activities related to the transfer of products into commercial manufacturing and technical support of ongoing commercial production. He holds a BS in pharmacy from the University of North Carolina and masters and doctorate degrees in pharmaceutical science from Rutgers University.
Message Presenter
Kyle D. Fugit, PhD., Associate Director, Technical Transfer, Mayne Pharma
As associate director of Technical Services for Mayne Pharma US, Kyle is responsible for evaluating new project opportunities and the transfer of products into commercial manufacture developed internally by Metrics Contract Services’ pharmaceutical development and from external manufacturing sites. He holds a BS in chemical engineering from the University of Alabama and a doctorate degree in pharmaceutical science from the University of Kentucky.
Message Presenter
Anshul Gupte, PhD., RAC, Senior Director, Scientific and Technical Affairs, Metrics Contract Services
As senior director of scientific and technical affairs, Anshul is responsible for the technical and scientific oversight of client projects at Metrics Contract Services. He works across various functional teams in RFP considerations and scope of work development, proposal delivery and client meetings. Anshul holds a Bachelor of Pharmacy from the RGPV University, Bhopal, India, a Master of Science in Pharmaceutical Sciences from Temple University, and a Doctorate in Pharmaceutical Sciences from the University of Kentucky.
Message PresenterWho Should Attend?
- General Managers or Site Heads
- Directors, VPs, or Managers of Manufacturing
- Technical Service and Technical Transfer Groups
- Pharmaceutical Development Groups
- Operations and Facility Personnel
- Quality Engineering and Quality Assurance Teams
- Environmental, Safety, and Health Groups
What You Will Learn
Register for this webinar to learn about:
- High-level overview of the scale-up and qualification process for new product launch
- Common issues that arise between registration and qualification (scale-up)
- Risk-based approaches to mitigating scaleup issues prior to registration — evaluating process robustness
- What data to collect and evaluate during registration batches
- Other considerations for registration manufacturing
Xtalks Partner
Metrics Contract Services
Metrics Contract Services is a science-led contract development and manufacturing organization engineered around customers. We harness complexity and deliver confidence to companies developing novel oral solid dose products. With a 25-year track record, we support pharmaceutical companies from initial concept to global commercialization. Our skilled scientists and expert operators provide pharmaceutical development, analytical testing and commercial manufacturing to over 100 customers worldwide from our facility in Greenville, NC — all under a single FDA registration. We specialize in smaller batches, ideal for orphan drug development and niche patient populations. Our strong compliance record and best-in-class equipment make us the ideal partner for your novel oral solid dose product. We’re serious about science and sharply focused on novel drugs that make a difference. Metrics Contract Services is a division of Mayne Pharma Inc.
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