Presenting: Director of Learning Jim Vesper, PhD; Senior Consultants Amanda McFarland; Stephen Langille, PhD; and Fred Ayers.
Moderating: Business Unit Manager Marc Glogovsky
Also Attending: Business Unit Manager Kelly Waldren, Senior Consultants Igor Gorsky; Ryan Murray; Darius Pillsbury, PhD; Tiffany Baker; Consultants Virginia Andreotti-Jones, James Wamsley, and Heather Hafer-DeMilto.
Join Valsource at the 2023 PharmaEd Microneedle & Intradermal Delivery Forum. Consultant Jessica Chiaruttini will be presenting on the topic of,“Microbiological Control for Intradermal Products: A Former Regulators Perspective.” ValSource Vice President of Business Development Brian Jordan will also be in attendance.
The 16th World Drug Delivery Summit on Pharmaceutics is on September 6-7, 2023 in London, England. ValSource Consultant Jessica Chiaruttini will be presenting in Track 20 on the topic of, “Navigating Regulatory Expectations for Microbiological Control of Microneedle Products.”
ValSource Senior Consultant Igor Gorsky is speaking on the topic of “Science and Risk Based Approach for Cleaning Validation” at the EBM 3rd Annual Cleaning Validation 2023 conference in Mumbai, India.
The 2023 PDA Pharmaceutical Manufacturing & Quality Conference entitled “The Way Forward: Trends, Technologies and New Regulations Transforming Pharmaceutical Manufacturing” is taking place on August 15 & 16, 2023 in Singapore. Don’t miss our Senior Consultant, Kim Sobien, speaking on the topic of Micro Strategy for CCS.
ValSource Director of Learning Solutions James Vesper, PhD, MPH is co-presenting Workshop 3: GMP101: An Overview of the Drug Product CGMPs. Topics will include Historical context of the US CGMPs, Characteristics of CGMP-compliant products, Seven essentials of GMPs, and Challenges in meeting the essentials.
San Diego, CA
Join Walter Henkels, Manager, Western Region; Brian Jordan, VP, Business Development; and Patrick Mains, Senior Consultant, at the ISPE San Diego Chapter meeting on June 29, 2023. The topic is “Manufacturing Best Practices: The Journey from Clinic to Commercialization.”
ValSource Consultants are headed to the upcoming 2023 ISPE Biotechnology Conference in Dublin, Ireland on June 27-28. Senior Consultant Darius Pillsbury will be presenting, “2B or not 2B? Readiness for the PPQ of a Cell Therapy.”
The PDA Advanced Therapy Medicinal Products Conference is taking place June 7-8 in Baltimore, MD. Don’t miss Darius Pillsbury, Senior Consultant, PDA ATMP Advisory Board member, and Cell & Gene Therapy Interest Group Lead’s moderating the session, “Manufacturing Process Design and Implementation: A Risk-Based and Science-Driven Approach and Ryan Murray, Senior Consultant, presenting the session, “A New PDA Points to Consider Document in the Making: Materials for ATMP Manufacturing”.
This discussion organized by the Pacific Northwest Chapter of the PDA & led by ValSource’s own Virginia Andreotti-Jones will focus on Risk Management Strategies and a portfolio of risk assessments that can be used to support a robust contamination control strategy.