Are You Ready to Validate Your Process?

Pharmatek Presents: Are You Ready to Validate Your Process? Steve Pondell Principal at Integrated BioTech Solutions May 15th, 2015 8:30 a.m. - 9:30 a.m. PDT Pharmatek, 7330 Carroll Rd., Suite 200, San Diego, CA 92121 *This PTEK U is also being offered as a webinar  Registration is Free & a Continental Breakfast will be Provided *Seminar attendees will be entered to win a $50 gift card to Karl Strauss Brewery.
	Click here to register for this seminar Presentation Summary As your clinical program enters Phase III, your CMC focus turns to selecting your commercial manufacturer and preparing for process validation.  This is the point where you should critically evaluate your developmental history, CMO/supply chain capability, and readiness in support of the process validation activity.  An expert CMC gap assessment and subsequent risk analysis program can assure that you have selected appropriate CMO’s, your process and analytical development is robust, and you are ready for a successful process validation.  This presentation will describe the elements and benefits of a CMC gap assessment, both in readiness for process validation and in readiness for NDA/BLA/MAA filing. About the Speaker Steve Pondell is a Principal at Integrated BioTech Solutions.  He is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production.  As an expert consultant, Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analyses, Phase I product development programs, cGMP compliance and supplier audits, and business development activities for a global logistics provider.  He has experience at working with small biotech companies as well as multi-national pharmaceutical companies.  He has served as a contract manufacturer and as a virtual manufacturing outsourcing manager.  His particular specialty is assisting companies work across the sponsor/contract manufacturing relationship, creating high performing partnerships on a global basis. Steve earned his Chemical Engineering degree from the University of Michigan and his MBA from the Lake Forest Graduate School of Management. Click Here to Register