Can ICH Q12 Unlock Manufacturing Innovation?

By: Ursula Busse, PhD MBA, Tigen Pharma and Melissa Seymour, MBA

Growing Acceptance of Real-Time Monitoring

Frank Panofen, Particle Measuring Systems

Getting Biosimilars Right the First Time

Barbara Rellahan, Amgen

Knowledge Grows for mAb Development

Martijn van der Plas, PhD, Medicines Evaluation Board, and Michael De Felippis, PhD, Eli Lilly

A Tale of Two Vials

Rebecca Stauffer, PDA

3-D Printing and Biopharmaceutical Manufacturing

Lina Genovesi

PDA Responds to Annex 1 Revision

Rebecca Stauffer, PDA

Container Closure Integrity Requires Adaptation

Dominick DeGrazio, PhD, Janssen R&D, LLC

RMAT Program Raises a Few Questions

Austin Caudle, IQVIA

Make New Buddies in Berlin

Rebecca Stauffer, PDA

Glass Versus Cyclic Olefin Polymers

James McCaw, West Pharmaceutical Services, Inc.

New Drugs Need Agile Biomanufacturing

Rebecca Stauffer, PDA

Speaking the Language of GMP

Rebecca Stauffer, PDA

PDA Celebrates Ten Years of ATMP Conferences

Rebecca Stauffer, PDA

Know Your Numbers for Analytical Similarity

Emanuela Lacana, PhD, U.S. FDA

ATMPs: What a Difference a Year Can Make

John Geigert, PhD, BioPharmaceutical Quality Solutions

Cell and Gene Therapies Present Challenges, Promise

Joshua Eaton, PDA

Novel Manufacturing Tech Drives Novel Product Development

Rebecca Stauffer, PDA

Glass Along the Value Chain

Claudia Heinl, PhD, Schott

Awareness Critical for Container Closure Components

Honoring PDA’s Female Volunteer Leaders

Martin VanTrieste

Smoke Signals

Tony Pavell, Fresenius Kabi

New Approach Suggests Continuous Lyophilization is Possible

Pieter-Jan Van Bockstal, Ghent University, Jos Corver, RheaVita, and Thomas De Beer, Ghent University

Seeing the Hidden

Rebecca Stauffer, PDA

New Tech Disrupts Traditional Aseptic Processing

2018 PDA Annual Meeting speakers

Adapt Your Nest-and-Tub System as the Industry Evolves

Gregor Deutschle, SCHOTT

New Trends Require Investment from Vaccine Makers

Cristiana Campa, GSK Vaccines, and Nancy Cauwenberghs, MSD

High Regulatory Expectations for Biosimilars

Stephan Krause, PhD, AstreZeneca Biologics, Emanuela Lacana, PhD, U.S. FDA, Jens Schletter, PhD, Sandoz, and Rebecca Stauffer, PDA

Teamwork Crucial to SUS Sterilization Validation

Polly Hanff, Saint-Gobain Performance Plastics

Formalizing a Risk Assessment for Excipients

Frithjof Holtz, Merck KGaA, Darmstadt, Germany

Extractables Testing of Aluminosilicate and Borosilicate Glass Containers

Daniel Kramer, Robert Schaut, PhD, Ela Bakowska, Misty Riesbeck, Alex Thomas, Steven Tietje, Corning Incorporated

Achieve True Manufacturing Reliability

Hal Baseman, ValSource, and Brett Duersch, Merck and Co.

Collaboration Through Mutual Reliance Brings FDA and EMA to the Table

Rebecca Stauffer, PDA

Monitor Viable Air with Single-Use, Real-Time Tech

Frank Panofen, PhD, Particle Measuring Systems

Disruptive Change is on the Horizon

Tia Bush, Amgen

Flexibility Needed for PAC

Rebecca Stauffer, PDA

Regulators Tackle Tough Micro Questions on Panel

Rebecca Stauffer, PDA

New PDA Task Force Targets Big Data

Michele D’Alessandro, Merck & Co., and Aaron Goerke, F. Hoffmann-La Roche Ltd.

Cracking the Challenges of Glass Packaging

Roger Asselta, Genesis Packaging Technologies

Millennials: How Manufacturers are Training the Next Generation

Rebecca Stauffer, PDA

Worst-Case Analysis of Cell Growth in SUS

Samuel Dorey, Sartorius

Isolator Surfaces and Contamination Risks to Personnel

By: Richard Denk, SKAN AG , Andreas Flueckiger, MD, Roche Group , Hirokazu Kisaka, Takeda Pharmaceutical Company , Reinhold Maeck, Boehringer Ingelheim , Lars Restetzki, PhD, Roche Group , Andreas Schreiner, PhD, Novartis , and Rico Schulze, Landesdirektion Sachsen

AIDC is a Sign of Things to Come: Part II

By: Napoleon Monroe, New Directions Consulting

AIDC is a Sign of Things to Come: Part I

By: Napoleon Monroe, New Directions Consulting

A Risk Assessment is an Opportunity Assessment

David Hubmayr, CSL Behring

PDA and IFPMA Foster Discussion on PAC

Ursula Busse, PhD, Novartis

Prefilled Syringe Manufacturing Moves Away from Hands-On Approach

J. Martin Bultmann

Five Keys to Manufacturing Success

R. J. Filannino, Alice Redmond, and Richard Tree, Commissioning Agents

Two Views on Packaging from Prefilled Exhibitors

Crystal Kraft, PhD, West Pharmaceutical Services, Inc., and Claudia Heinl, PhD, Schott AG

One Company’s Approach to Rapid Micro Methods

Mousumi Paul and Scott Hooper, Merck Sharp and Dohme Corp.

New Realities for Prefilled Syringes

Mathias Romacker, Pfizer, Conference Scientific Program Planning Committee, with Rebecca Stauffer, PDA

Novel Drug Products Drive New Views on Suitability

Diane Paskiet, West, and Ronald Iacocca, PhD, Eli Lilly and Company

Visual Inspection Faces Changing Environment

John D. Ayres, MD, Eli Lilly and Company

One Simple Way to Manage Aseptic Risk Assessments

Guenther Gapp, Independent Consultant

Four Steps to Ensuring Data Integrity for BET

Jennifer Farrington, PhD, Associates of Cape Cod, Inc.

Company Sees Success With Automated Endotoxin Testing

By: Scott Kaszuba, Pfizer

Why the Surface is Critical to Disinfection Testing

By: Jim Polarine Jr., MA, STERIS Corporation and David Shields, STERIS

PQS: An Effective Lever for Managing PACs

Anders Vinther, Sanofi Pasteur, Emma Ramnarine, Genentech/Roche, Kevin O’Donnell, Irish Health Products Regulatory Authority

The Future of Cell and Gene Therapies is Here

Austin Caudle, Metabolon, Inc.

The Cost of Microbial Control

Edward Tidswell, PhD, Merck, and Walid El Azab, Steris

A Stepwise Approach to Effective Data Management and Analysis

Gilberto Dalmaso, PhD, Particle Measuring Systems

Women in Biotech Panel Offers Career Advice for All Sexes

Fabio De Martino, PDA West Coast Chapter President-elect, F. Hoffmann La-Roche, and Beth C. Keij, Sangamo Therapeutics

Difficult-to-Inspect Drugs Require New Processes

Rick Watson, Merck & Co., Inc.

Can Single-Use Components Be Commodities?

Sabrina Restrepo, PhD, Merck, and Christopher J. Smalley, PhD, ValSource

When Microbiologists Collaborate, Great Things Happen

Marsha Steed (Hardiman), ValSource

Build Your Network at the PDA/FDA JRC

Rebecca Stauffer, PDA

OPQ Establishes Manufacturing Science CoE

Kurt Brorson and Sau L. Lee, U.S. FDA

A Maturing Model of Quality

Jacqueline Kunzler, PhD, Baxter International Inc.

Industry Expert Weighs in on Quality Metrics

Rebecca Stauffer, PDA

U.S., UK Regulators Share Passion for Quality Culture

Rebecca Stauffer, PDA

PDA’s 4th Metrics Conference

Stephanie Gaulding, DPS Engineering

Knowledge is Power

Rafik H. Bishara, PhD, Eli Lilly and Company (retired) and Erik van Asselt, PhD, MSD

Perspectives on Packaging

Rebecca Stauffer, PDA

Industry Experts: Quality Requires Proactive Approach

Rebecca Stauffer, PDA

The Future of Glass in Parenteral Packaging

Robert A. Schaut, PhD, and W. Porter Weeks, Corning Incorporated

New Guidance for Visual Inspection Available

Roy Cherris, Bridge Associates International

MAbs Require Ongoing Dialogue

Ursula Busse, PhD, Novartis, and Steffen Gross, Paul-Ehrlich-Institut

Prefilled Syringes Bring Patient to the Forefront

Mathias Romacker, Pfizer, and Hanns-Christian Mahler, Lonza

How to Use QbD to Select Packaging Components

Nrupa Patel, Teligent Pharma Inc., and Sandip Patel, Navinta LLC

Putting the Pieces Together

By: Wendy Saffell-Clemmer, Baxter Healthcare

Creating a Global Incentive for Pharma

Anders Vinther, Sanofi Pasteur; Emma Ramnarine, Genentech; co-chairs PDA Post Approval Change: Innovation for Availability of Medicines (PAC iAM) Task Force

Lower the H202 Concentrations in Your Isolator with One Easy Upgrade

By: Stefan Kleinmann, PhD, METALL + PLASTIC GmbH , Matthias Scheu, METALL + PLASTIC GmbH , Roland Schuhwerk, Cilag AG , and Volker Baur, Cilag AG

Hear From Industry, FDA Leaders on the Issues of the Day

Susan Schniepp, Regulatory Compliance Associates, and Steven Mendivil, Amgen

Pharma Has its Head in the Cloud

By: Toni Manzano, Aison

A Case Study in Aseptic Gas Plasma Decontamination

Egmont Semmler, Groninger & Co.

Regulators, USP Taking a Close Look at Visual Inspection

John Shabushnig, PhD, Insight Pharma Consulting, and Markus Lankers, PhD, rap.ID Particle Systems GmbH

Human Element Key to Digital Transformation

Rebecca Stauffer, PDA

A QUICK Guide To Selecting a CMO

Brittany Cloud, Eurofins Lancaster Laboratories, Inc.

IG Meetings to Address Complexity of New Products

Lee Leichter, P/L Biomedical

How to Get Your ATMP From the Lab to the Market

By: Andy Fry, Team Consulting

Viral Safety Approaches for Advanced Therapy Medicinal Products

Thomas R. Kreil, PhD, Global Pathogen Safety, Shire

WHO Should Align with ICH on PACs

Rebecca Stauffer, PDA

Quality Metrics to Impact Different Pharma Sectors

Rebecca Stauffer, PDA

Leveraging Video to Improve Operations

Colleen Walson-Billin, Amgen

Storm Surrounds Clinical Trial Data in China

Yingying Liu, ECURAC, and Siegfried Schmitt, PAREXEL

Annex 1 Showcases the Need for Clear Guidance

Geert Vandenbossche, Novartis; Marc Besson, Sanofi; Gabriele Gori, GSK Vaccines; Jette Christensen, Novo Nordisk; Gerry Morris, Eli Lilly and Company

GMP Oversight of Medicines Manufacturers in the European Union

Riccardo Luigetti, EMA, Emer Cooke, EMA, Brendan Cuddy, EMA, Sebastien Goux, European Commission, and Ian Rees, MHRA

A Line of Sight Approach for Assessing Aseptic Processing Risk: Part III

Hal Baseman, Marsha Hardiman, Walter Henkels and Mike Long, ValSource

PDA Program to Address Post-Approval Hurdles

PDA Post Approval Change: Innovation for Availability of Medicines (PAC iAM) Task Force

Four Steps to Conducting a Successful Data Integrity Audit

Crystal Mersh, Quality Executive Partners