In this issue, PDA features a case study on quality risk management implementation, which was presented at the 2006 PDA/FDA Joint Regulatory Conference. In “OOS Final Guidance: What Has Changed?” Lynn Torbeck, PhD, Torbeck & Associates, discusses the numerous revisions made by FDA to...

In this issue, David Porter, PhD, Vectech Pharmaceutical Consultants, reports on US Pharmacopeia general chapters relevant to microbiologists in “Review of USP Microbiology Chapters,” based on discussions at PDA’s Global Conference on Pharmaceutical Microbiology.

In this issue, Jim Lyda, PDA, presents his perspective, “PIC/S: Why is It Important? What is Its Impact?,” on what makes PIC/S important for a PDA member. PDA President Bob Myers reports on recent donations to the new TRI facility and calls for the continued support of PDA members. PDA Program Co-chairs, Norbert Hentschel,...

In this issue, PDA’s Robert Dana and Gail Sherman recount EMEA Inspection Sector Head Emer Cooke’s discussion on the future of pharmaceutical manufacturing at the recent ISPE/PDA cosponsored Workshop on ICH Q8, Q9 and Q10. The FDA’s take on the meaning of these guidances is presented by Rick Friedman...

In this issue, we celebrate TRI’s 10th Anniversary with articles from PDA staffers Gail Sherman, James Wamsley, Jessica Petri, Walter Morris and Lindsay Donofrio. We are pleased that former members of the PDA staff Russell Madsen and Bob Mello also contribute.

In this issue, CDER talks with PDA about the recent release of a U.S. FDA guidance titled, Testing of Glycerin for Diethylene Glycol and an associated MedWatch Safety Alert. In “Use of Microarrays to Evaluate Cell Culture Processes,” Michael Hanson, a recipient of a PDA Journal student grant, provides a summary...

PDA Managing Editor Walter Morris previews the new science contained in the recently published TR-1 (Revised 2007). The “Science & Technology Snapshot” updates readers on PDA technical reports, the PDA journal, task forces, leadership opportunities and Sci-Tech Trends. In “Review of EMEA Guideline: Limiting Residues of...

A team from Hospira provides a comprehensive examination of compendial standards for analytical method validation. PDA’s Jim Lyda interviews Bill Paulson on his new publication, International Pharmaceutical Quality, and talks with Sabine Paris, PhD, about the role of ZLG, the German heath authority.

In this issue, Bert Frohlich, Amgen highlights the Quality by Design for Biopharmaceuticals workshop with his article entitled, QbD: Still in Design. Dieter Bachmann, Cilag and Ike Harper, Johnson and Johnson, write about low energy electron beam applications in Aseptic filling operations.

In this issue of the PDA Letter, PDA’s Walt Morris reports on the 2007 PDA/FDA Conference and provides an overview of Japan’s foreign inspection program based on discussions at the Japanese Regulatory Workshop. The issue’s “Faces and Places” is comprised of photos from the PDA/FDA sessions, exhibits and gala event.