Dennis Guilfoyle, PhD, discusses sterility test failure investigations at the 14th Annual PDA Global Conference on Pharmaceutical Microbiology.
Amgen’s Chakradhar Padala discusses the latest developments in aseptic processing at the 2019 PDA/FDA Joint Regulatory Conference.
Kevin Jenkins, Pfizer (now retired), talks about how to conduct an effective deviations investigation.
Former PDA Chair Martin VanTrieste talks about why PDA’s new purchasing controls standard is needed.
Two volunteers from the PDA Southern California’s student chapter talk about volunteering at the 2019 PDA Annual Meeting.
Sanofi’s Cheryl Essex discusses her company’s equipment inspection program at the 2018 PDA Microbiology Conference.
Keck Graduate Student Lyanna Jauregui discusses her poster at the 2019 PDA Annual Meeting with Jason Kerr.
Gateway Analytical’s Antonio Scatena discusses USP <1790> at the 2019 PDA Visual Inspection Forum.
West Pharma’s Amy Kim and Biogen’s Maria Bednar discuss their Young Professionals presentations at the 2019 PDA Annual Meeting.
Diane Paskiet of West Pharmaceutical Services discusses the impact of <1207> on container closure integrity testing.
SKAN’s Richard Denk discusses EU requirements to prevent cross-contamination at the 2019 PDA Annual Meeting.
Emergent’s Kevin Gadient provides insights on implementation of a gloveless, robotic isolator.
Merck’s Kenneth Boone covers recovery of anaerobic microorganisms from an aerobic aseptic process simulation.
Roche’s Aaron Goerke talks about what big data means for pharma manufacturing.
Novartis’ Christian Scheidl discusses the role of audit trails for ensuring data integrity at the 3rd PDA Europe Annual Meeting.
U.S. FDA’s Francis Godwin address what FDA and industry learned about ensuring the safety of the pharmaceutical supply chain after the heparin crisis.
The U.S. FDA’s Dan Mellon provides the Agency’s perspective on extractable and leachable control for packaging components. Read a transcript of the video.
Rebecca Stauffer from the PDA Letter interviews BioLife Solutions’ Brian Hawkins about his poster on assessing cell viability after cryopreservation at the 2018 PDA Annual Meeting. Click here to read his article on topic.
PDA board member Masahiro Akimoto interviews the Japan PMDA’s Issei Takayama on Japanese regulations for continuous manufacturing at the 2018 PDA Annual Meeting.
Annual Meeting speaker Ute Schleyer from Vetter discusses the company’s new isolator/RABS technology. Read more about the technology here.
PDA Education instructor Elaine Lehecka Pratt discusses the role of quality culture in preventing human error.
Corning’s Timothy Hunt discusses planned revisions the USP chapter <660> Containers-Glass.
Bristol-Myers Squibb’s Paula Peacos discusses her experience using contamination recovery rates for trending environmental monitoring data. Click here to read more about this process.
Baxter’s Kevin Cloonan discusses how the company has achieved success using a Quality System Maturity Model.
Amgen’s Arleen Paulino discusses next generation manufacturing at the company’s facility in Singapore.
NNE’s Alex Severin discusses how to design for flexible engineering at the 2nd PDA Europe Annual Meeting in Berlin.
Pfizer’s Jeffrey Weber discusses how biofluorescent particle counting can benefit a manufacturer’s operations.
Karen Walker talks about how Novartis actualized a cell therapy.
Merck’s Director of Vaccine Operations and 2017 PDA Annual Meeting speaker Lisa Sykes discusses flexible manufacturing.
Hear from three PDA Letter authors and upcoming authors on outsourcing relationships, microbial control strategies, and organizational ability.
Amgen's Cylia Chen-Ooi discusses how quality culture relates to the US FDA’s quality metrics initiative.
PDA Education instructor Mary Carver discusses the latest in aseptic processing cleaning and disinfection.
Expert Committee Member David Hussong discusses recent changes to USP’s general chapters relating to pharmaceutical microbiology.
Find out what PDA’s Post Approval Change: Innovation for Availability of Medicines (PAC iAMSM) Task Force is doing to tackle the challenges companies face when trying to implement post-approval changes. Sanofi Pasteur’s Anders Vinther and Genentech’s Emma Ramnarine offer their insights.
What does it mean for manufacturing when a company's product receives Breakthrough Therapy status? AbbVie's Andrew Storey explains onsite at the 2016 PDA/FDA Joint Regulatory Conference.
PDA Chair Martin VanTrieste talks about new serialization requirements in Europe and their impact on the global pharmaceutical supply chain.
Merck Manufacturing CIO Michele D'Alessandro explores the Factory of the Future and the skillsets needed to bridge the gap between IT and manufacturing.
Merck Manufacturing CIO Michele D'Alessandro discusses how Big Data is driving changes in the industry.
Merck Manufacturing CIO Michele D'Alessandro looks at IT’s impact on pharma manufacturing.
In our second "On the Issue" video, find out how PDA’s Code of Conduct can help your company address the importance of data integrity.
In the first PDA Letter On the Issue video, members of PDA's Data Integrity Task Force offer their insights on the important topic of data integrity. Plus, find out what PDA is doing to help industry in this area.