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Audit Trails

Novartis’ Christian Scheidl discusses the role of audit trails for ensuring data integrity at the 3rd PDA Europe Annual Meeting.


Heparin Crisis: 10 Years Later

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.


Packaging Components: Extractable/Leachable Control

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.


Cell Viability After Cryopreservation

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.


Japanese Regulatory Considerations: Continuous Manufacturing

PDA board member Masahiro Akimoto interviews the Japan PMDA’s Issei Takayama on Japanese regulations for continuous manufacturing at the 2018 PDA Annual Meeting.


3 Questions on a New RABS/Isolator Combination

Annual Meeting speaker Ute Schleyer from Vetter discusses the company’s new isolator/RABS technology. Read more about the technology here.


Strategies for Reducing Human Error Nonconformances

PDA Education instructor Elaine Lehecka Pratt discusses the role of quality culture in preventing human error.


USP <660> Containers-Glass

Corning’s Timothy Hunt discusses planned revisions the USP chapter <660> Containers-Glass.


Contamination Recovery Rates in Low-bioburden Facilities

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.


Quality System Maturity Model

Baxter’s Kevin Cloonan discusses how the company has achieved success using a Quality System Maturity Model.


Next Generation Manufacturing

Amgen’s Arleen Paulino discusses next generation manufacturing at the company’s facility in Singapore.


Flexibility by Design

NNE’s Alex Severin discusses how to design for flexible engineering at the 2nd PDA Europe Annual Meeting in Berlin.


Continuous Microbial Monitoring: Four Points to Consider

Pfizer’s Jeffrey Weber discusses how biofluorescent particle counting can benefit a manufacturer’s operations.


Cell and Gene Therapies: 5 Keys to Industrialization

Karen Walker talks about how Novartis actualized a cell therapy.


Straight-Through Processing: Strategies for Implementation

Merck’s Director of Vaccine Operations and 2017 PDA Annual Meeting speaker Lisa Sykes discusses flexible manufacturing.


Editor’s HotSeat

Hear from three PDA Letter authors and upcoming authors on outsourcing relationships, microbial control strategies, and organizational ability.


Defining the Quality Culture

Amgen's Cylia Chen-Ooi discusses how quality culture relates to the US FDA’s quality metrics initiative.


Cleaning and Disinfection for Pharmaceutical Manufacturing

PDA Education instructor Mary Carver discusses the latest in aseptic processing cleaning and disinfection.


Update on USP Microbiology General Chapters

Expert Committee Member David Hussong discusses recent changes to USP’s general chapters relating to pharmaceutical microbiology.


Post-Approval Changes and the Industry

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.


The Impact of Breakthrough Therapies on Manufacturing

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.


New European Serialization Requirements

PDA Chair Martin VanTrieste talks about new serialization requirements in Europe and their impact on the global pharmaceutical supply chain.

Harnessing IT in Manufacturing: Part III The Future

Merck Manufacturing CIO Michele D'Alessandro explores the Factory of the Future and the skillsets needed to bridge the gap between IT and manufacturing.

Harnessing IT in Manufacturing: Part II Latest Trends

Merck Manufacturing CIO Michele D'Alessandro discusses how Big Data is driving changes in the industry.

Harnessing IT in Manufacturing: Part I Setting the Stage

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.