On The Issue: PDA India Chapter

Chapter leaders Rishikesh Jaiwant and Vishal Sharma discuss the successes and bright future of the PDA India Chapter..

On The Issue: PDA Training

Dave Talmage, VP of Education, discussing PDA training and new initiatives. PDA members can look forward to an expansion of global, on-site, and virtual reality offerings in the coming years. Dave spoke to Walter Morris at the 2023 PDA/FDA Joint Regulatory Conference.

On The Issue: The Quality Management Maturity Model

Denyse Baker discusses the PDA Quality Management Maturity Model and Task Force. She’s worked with the group since her days on PDA’s staff and continues as a volunteer from Eli Lilly. Denyse joined Walter Morris at the 2023 PDA/FDA Joint Regulatory Conference.

On The Issue: A Talk with Pulitzer Prize Winner Dominic Gates: Quality Culture

Walter Morris talks to Dominic Gates just after his presentation at the 2023 PDA/FDA Joint Regulatory Conference. Mr. Gates won the 2020 Pulitzer Prize for National Reporting about the internal quality problems at Boeing that contribute to the deadly crashes of two 737 MAX aircraft.

On The Issue: 2023 Partnership Award Winners

Guest host Bettine Boltres of the PDA Board of Directors talks with the winners of the 2023 PDA Drug Delivery Innovation Partnership Award.

On The Issue: 2023 PDA Drug Delivery Innovation Award

In this episode, Teodora Caragea talks about the PDA Drug Delivery Innovation Award, which she received on behalf of Merck KGaA Darmstadt Germany at the Universe of Pre-Filled Syringes and Injection Devices Conference in Gothenburg, Sweden.

The company was selected for the award for their digital platform for enhanced adherence tracking for a growth hormone deficiency injectable treatment.

On The Issue: The Digitalization IG & Task Force

In this edition of OTI, the leaders of PDA’s new Digitalization Interest Group talk about the latest projects, including the formation of a Task Force on Digitalization.

On The Issue: 2022 PDA Partnership Innovation Award

The 2022 PDA Partnership Innovation Award winners, Stevanato Group and Bexson Biomedical talk are featured in this edition of On The Issue.

On The Issue: Digitalization of C.C.

PDA’s Walter Morris chats with Sheba Zaman of Novatek International about Digitalization with the extra “I”. The two met at the 2023 PDA Annual Meeting in New Orleans in April, where Sheba presented on the topic.

On the Issue: The PDA/FDA Joint Regulatory Conference

PDA’s Walter Morris chats with Keisuke Inoue, a member of the Japan Chapter, about his experience at his first PDA/FDA Joint Regulatory Conference. Keisuke helped PDA translate the Japan Chapter technical report on environmental control for non-sterile products.

On the Issue: The 2022 PDA Micro Conference Co-Chairs

Josh Eaton, PDA, speaks with the conference chairs for the 2022 PDA Pharmaceutical Microbiology Conference. Vineeta Pradhan, U.S. FDA and Mitch Garber, 2seventybio, talk about the benefits of returning to an in-person event and their favorite sessions. Both serve on the committee for the 2023 event.

On The Issue: Data Integrity with Kir Henrici

Kir Henrici, Founder & CEO of the Henrici Group, speaks with PDA’s Walter Morris about the 2022 Data Integrity Workshop, Interest Group, and forthcoming Technical Report. The two met during the 2022 PDA/FDA Joint Regulatory Conference, a day before the workshop.

On the Issue: Philippe Germanaud, Part 3

In this edition of OTI, PDA’s Walter Morris concludes his interview with long-time member Philippe Germanaud, who recently retired after 30 years with Sanofi and 41 years in the industry. In this final installment, Philippe offers his assessment of the industry and advice for early career professionals.

On The Issue: Former Sanofi CQO Philippe Germanaud Part 2

In this edition of OTI, PDA’s Walter Morris talks to long-time member Philippe Germanaud, who recently retired after 30 years with Sanofi and 41 years in the industry. His last position was Chief Quality Officer with Sanofi. He is also a long-time PDA member. In part 2 of this 3-part series, Philippe discusses the role of quality and evolving technologies and how quality must be prepared for emergency conditions in the wake of the COVID-19 pandemic.

On The Issue: Philippe Germanaud

In this edition of OTI, PDA's Walter Morris talks to long-time member Philippe Germanaud, who recently retired after 30 years with Sanofi and 41 years in the industry. His last position was Chief Quality Officer with Sanofi. He is also a long-time PDA member. In part 1 of this 3-part series, Philippe discusses his unique path to joining the industry and rising up to a quality executive.

On The Issue: The Future of Batch Records

PDA's Glenn Wright spoke with Yves Blandiaux, salamanderU, about the future of batch records in aseptic environments at the 2022 PDA ATMP Conference in Brussels.

On The Issue: The 2022 PDA ATMP Conference

The co-chairs of the 2022 PDA ATMP Conference, Dayue Chen and Richard Denk, discuss with PDA EU’s Falk Klar the changing landscape and product types in the realm of advanced therapies. They also talk about the successful return to an in-person event in 2022.

On The Issue: Next Gen Sequencing

MilliporeSigma's Bradley Hasson discusses next generation sequencing. He gave a formal presentation on the topic at the 2022 PDA EU Virus Conference.

On the Issue: The PDA Virus Conference Chairs

The latest On The Issue is a discussion with the co-chairs of the 2022 PDA Virus Conference, the tenth to take place in Europe. PDA Europe’s Falk Klar sits with chairs Alison Armstrong, Merck, and Thomas Kreil, Takeda.

On the Issue: PDA Technical Report No. 41 Revised

The PDA Letter re-launches the On The Issue video series. In this edition, PDA’s Glenn Wright interviews Sebastian Teitz, Asahi Kasei Bioprocess, on the publication and release of PDA Technical Report No. 41(Revised 2022): Virus Retentive Filtration at the 2022 PDA ATMPs Conference in Brussels, Belgium in June 2022.

Past Leader Spotlight: John Shabushnig

After determining the Machine Vision Association was too “automotive” and AAPS was too “development,” John Shabushnig decided that PDA was “just right”...well, after it was agreed to hold a breakfast session on visual inspection at the Annual Meeting.

PDA’s 75th Anniversary: Nikki Mehringer, Volunteered to Volunteer

When Nikki Mehringer became PDA Chair in 2004, it capped several years of service to the Association. She describes how a former supervisor put her name forth as the new leader of the new PDA QA/QC Interest Group. After she was selected, he informed Nikki of her new role! There was no looking back for Nikki from then on.

Past Leader Spotlight: Rebecca Devine

From FDA CBER to PDA Chair: Immediate Past Chair, Rebecca Devine, talks about her long-time involvement with PDA activities and the value of volunteering.

PDA's 75th Anniversary: Past Leadership Spotlight

In this Past Leader Spotlight, Hal Baseman, Maik Jornitz and Martin Van Trieste speak about their time as PDA volunteers and how it has impacted their careers.

CCI Testing with Lauren Lavec

The PDA Letter team sat down with PPD's Lauren Lavec to discuss container closure integrity testing.

Sterility Test Failure Investigations with Dennis Guilfoyle, PhD, Johnson & Johnson

Dennis Guilfoyle, PhD, discusses sterility test failure investigations at the 14th Annual PDA Global Conference on Pharmaceutical Microbiology.

Innovations in Aseptic Processing

Amgen’s Chakradhar Padala discusses the latest developments in aseptic processing at the 2019 PDA/FDA Joint Regulatory Conference.

Deviations Investigation with Kevin Jenkins

Kevin Jenkins, Pfizer (now retired), talks about how to conduct an effective deviations investigation.

PDA’s Purchasing Controls Standard with Martin VanTrieste

Former PDA Chair Martin VanTrieste talks about why PDA’s new purchasing controls standard is needed.

Here They Come: Young Professionals

Two volunteers from the PDA Southern California’s student chapter talk about volunteering at the 2019 PDA Annual Meeting.

Equipment Inspection Program

Sanofi’s Cheryl Essex discusses her company’s equipment inspection program at the 2018 PDA Microbiology Conference.

Here They Come: Pharma Students

Keck Graduate Student Lyanna Jauregui discusses her poster at the 2019 PDA Annual Meeting with Jason Kerr.

Here They Come: Pharma Young Professionals

West Pharma’s Amy Kim and Biogen’s Maria Bednar discuss their Young Professionals presentations at the 2019 PDA Annual Meeting.

USP <1207> and the Future of CCI Testing

Diane Paskiet of West Pharmaceutical Services discusses the impact of <1207> on container closure integrity testing.

Controlling Contamination and Cross-Contamination

SKAN’s Richard Denk discusses EU requirements to prevent cross-contamination at the 2019 PDA Annual Meeting.

Implementing a Completely Closed, Robotic Isolator for Flexible Filling of Protein Products

Emergent’s Kevin Gadient provides insights on implementation of a gloveless, robotic isolator.

P. Acnes in an Aerobic Process

Merck’s Kenneth Boone covers recovery of anaerobic microorganisms from an aerobic aseptic process simulation.

Big Data

Roche’s Aaron Goerke talks about what big data means for pharma manufacturing.

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.