http://www.pda.org/MainMenuCategory/Chapters/New-England.aspxWelcome to the PDA New England Chapter (NEPDA) website.Copyright 2008en-usFri, 12 Mar 2010 09:23:03 GMT1http://www.pda.org/MainMenuCategory/Chapters/New-England/About-Us.aspxN/ASun, 29 Mar 2009 12:27:21 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration.aspx?ET=Chapter&R=&M=&Y=&Q=&C=0&SO=StartDate%20ASC&CH=25542N/ATue, 09 Jun 2009 15:21:38 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events.aspxN/AThu, 19 Feb 2009 16:12:37 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/New-England-Chapter-May-2010-Dinner-Meeting-and-Facility-Tour.aspxN/AThu, 08 Oct 2009 11:24:53 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/NEPDA-April-2010-Business-Meeting.aspxN/AThu, 08 Oct 2009 13:05:17 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/New-England-Chapter-March-2010-Dinner-Meeting-and-Facility-Tour.aspxN/AThu, 08 Oct 2009 11:19:32 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/NEPDA-February-2010-Business-Meeting.aspxN/AThu, 08 Oct 2009 12:53:00 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/Changes-to-USP-Sterilization-Chapters.aspxN/AThu, 08 Oct 2009 09:04:09 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/NEPDA-December-2009-Business-Meeting.aspxN/AThu, 08 Oct 2009 12:49:41 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/Depth-Filtration.aspxN/ATue, 02 Jun 2009 14:23:40 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/NEPDA-October-2009-Business-Meeting.aspxN/AThu, 08 Oct 2009 11:36:55 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/Dinner-Meeting--Hot-Topics-in-Environmental-Monitoring.aspxN/AFri, 08 May 2009 08:59:05 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/Container-Closure-Integrity-Dinner-Meeting.aspxPDA Technical Report 27: "Container-Closure Integrity" Speakers: Roger Asselta, Vice President of Technical Affairs, Genesis Packaging Technology Heinz Wolf, General Manager, Packaging Technologies and Inspection LLC Thu, 19 Feb 2009 16:16:12 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/PDA-New-England-Chapter-Presents-PDA-TR-15-Validation-of-Tangential-Flow-Filtration-in-Biopharmace.aspxN/AFri, 08 May 2009 08:08:28 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Upcoming-Events/NEPDA-Business-Meeting-Registration.aspxN/AThu, 29 Oct 2009 12:12:48 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations.aspxN/ASun, 29 Mar 2009 12:26:40 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/USP-Activities-Impacting-Sterilization-Sterility-Assurance.aspxJanuary 2010, by James Agalloco, Agalloco & Associates (1,721 KB)Fri, 22 Jan 2010 16:07:50 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Environmental-Monitoring-A-New-Look-at-an-Old-Topic.aspxSeptember 2009, by Jeanne Moldenhauer, Excellent Pharma Consulting (335 KB) Thu, 17 Sep 2009 10:45:31 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Test-Method-for-Indirect-Measurement-of-Elastomeric-Closure-Compression-Using-an-Automated-Residual-.aspxMarch 2009, by Roger Asselta (6.59 MB)Mon, 13 Apr 2009 15:38:35 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Non-Destructive-Container-Closure-Integrity-Testing-.aspxMarch 2009, by Heinz Wolf (6.24 MB)Mon, 13 Apr 2009 15:36:31 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/A-Survey-of-Industry-Practice-for-the-Visual-Inspection-of-Injectable-Products-Preliminary-Report.aspxJanuary 2009, by Ronald L. Leversee & John G. Shabushnig, Ph.D. (839 KB) Mon, 13 Apr 2009 15:29:34 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Technology-Update-Automated-Inspections.aspxJanuary 2009, by Michael W. de la Montaigne (2.72 MB) Mon, 13 Apr 2009 15:27:48 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/HOT-TOPICS-in-the-Visual-Inspection-of-Injectable-Products-.aspxJanuary 2009, by John G. Shabushnig, PhD (1.52 MB)Mon, 13 Apr 2009 15:26:20 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/PDA-Biopharmaceutical-Cleaning-Validation-Task-Force-TR29-Initiating-Good-Cleaning-Practices.aspxNovember 2008, by Richard Jushchyshyn, Principal, Hyde Engineering + Consulting, Inc. (42 KB) Mon, 13 Apr 2009 15:22:51 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Maintaining-Good-Cleaning-Practices.aspxNovember 2008, by Kathleen Kendrick, Validation Technology Manager (587 KB) Mon, 13 Apr 2009 15:07:58 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Application-of-Track-Trace-Technologies-to-Containers.aspxSeptember 2008, by Michael N. Eakins, Ph.D., Principal Consultant, Eakins & Associates (560 KB) Mon, 13 Apr 2009 14:32:32 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Environmental-monitoring-using-a-rapid-non-destructive-automated-compendial-method.aspxMarch 2008, by Andrew Sage, Principle Scientist Rapid Micro Biosystems (4.85 MB) Mon, 13 Apr 2009 14:28:17 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Decon-20-Emerging-Decontamination-Technologies.aspxMarch 2008, by Peter Harris, Director of Operations B & V Testing, INC. (1.21 MB)Mon, 13 Apr 2009 14:06:58 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/MassBioLogics-Tour-Presentation.aspxMarch 2008 (1.48 MB)Mon, 13 Apr 2009 14:01:42 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/USP-Guidances-on-Environmental-Control-Including-related-USP-FDA-EMEA-PDA-Activities.aspxMarch 2008, James Agalloco (893 KB)Mon, 13 Apr 2009 13:54:32 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Copy of Test-Method-for-Indirect-Measurement-of-Elastomeric-Closure-Compression-Using-an-Automated-Residual-.aspxN/AThu, 12 Mar 2009 13:28:26 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Steam-Sterilization-and-the-2007-Revision-of-PDA-Technical-Report-1.aspxNovember 2007, by Don Drew and Mike Fingers (1.39 MB)Mon, 13 Apr 2009 13:53:21 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/TR40-Sterilizing-Filtration-of-Gases-A-comparison-withTR26-Sterilizing-Filtration-of-Liquids.aspxJune 2007, by Leesa McBurnie, Sr. Microbiologist Meissner Filtration Products, Inc. (247 KB) Mon, 13 Apr 2009 13:48:56 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/PDA-Technical-Report-No-26-Sterilizing-Filtration-of-Liquids.aspxJune 2007, by Jerry Martin, Sr. Vice President, Scientific Affairs Pall Life Sciences (519 KB) Mon, 13 Apr 2009 13:45:55 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/The-story-behind-the-story-What-the-PDA-Technical-Report-39-is-all-about.aspxApril 2007, by Sarvang Mishra, Senior Engineer, Wyeth (1.23 MB)Mon, 13 Apr 2009 13:44:30 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Global-Cold-Chain-Regulations-Influencing-Storage-Handling-and-Distribution-of-Clinical-Trial-Mate.aspxApril 2007, by Henry Ames, Director of Strategic Marketing, Sensitech (227 KB)Mon, 13 Apr 2009 13:42:28 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Global-Validation-Requirements-The-Principles-of-ICH-FDA-USP-Ph-Eur-JP.aspxFebruary 2007, by Susan Schniepp, Quality Manager, Hospira, Inc. (1.36 MB)Mon, 13 Apr 2009 13:40:42 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Multi-Product-Biopharmaceutical-Manufacturing-Facilities.aspxNovember 2006, by E Hoglund (179 KB) Mon, 13 Apr 2009 13:28:19 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Selection-of-a-Contract-Aseptic-FillFinish-Manufacturer-.aspxJanuary 2006, by John Dobiecki (164 KB) Mon, 13 Apr 2009 13:26:17 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Responding-to-a-Form-483-or-Warning-Letter.aspxMay 2006, by Mark Lookabaugh (4.39 MB)Mon, 13 Apr 2009 13:25:06 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/cGMP-Pitfalls-in-the-QC-Laboratory-Preparing-the-QC-Laboratory-and-Staff-for-an-FDA-Inspection-.aspxMay 2006, by Michelle Sceppa (53 KB) Mon, 13 Apr 2009 13:08:45 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/FDAs-High-Risk-Drug-Systematic-Approach-to-Inspections.aspxMay 2006, by Stephen Souza. (100 KB)Mon, 13 Apr 2009 13:06:10 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Identification-of-Microorganisms-Using-Comparative-DNA-Sequencing.aspxFebruary 2006, by Michael Waddington, Accugenix, Inc. (869 KB) Mon, 13 Apr 2009 13:04:15 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/The-Extra-Work-that-Goes-into-Building-a-Manufacturing-Facility-When-it-is-FDA-Regulated-.aspxApril 2005, by Jorge Ferreira, Director of Aseptic Processing and Fill/Finish Technologies for Washington Group International (389 KB)Mon, 13 Apr 2009 13:02:50 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/An-Ongoing-Program-to-Assess-Key-Quality-Elements-at-Genzyme-.aspxApril 2005, by Todd Snell, Associate Director of Corporate Quality for Genzyme (431 KB)Mon, 13 Apr 2009 13:01:13 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Strategies-for-Monitoring-and-Troubleshooting-Biopharmaceutical-Operations-.aspxApril 2005, by Jack Prior, Associate Director of Technical Services for Genzyme. (1.26 MB) Mon, 13 Apr 2009 12:58:13 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Visual-Inspection-of-Injectable-Products-More-Than-Just-Sorting-Good-from-Bad-.aspxFebruary 2005, by John G. Shabushnig, PhD, Senior Manager, Pfizer Global Quality Technical Services (1.54 MB) Mon, 13 Apr 2009 12:51:06 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/The-Harmonized-PAT-Solution-Application-of-Risk-Based-Tools-Process-Analytical-Technology-Strateg.aspxDecember 2004, by Jeffrey A. Priem, Principal Consultant, Barnett International (PAREXEL Consulting)" (773 KB) Mon, 13 Apr 2009 12:46:21 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Process-Analytical-Technologies-PAT-PAT-Risk-Based-Initiatives-Doing-the-Business-a-European.aspxDecember 2004, by Cliff Campbell, CC&A Ltd. (162 KB) Mon, 13 Apr 2009 12:44:54 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Development-and-Commercialization-of-Combination-Products-The-Commercialization-of-an-Iontophoretic.aspxOctober 2004, by George M. Baskinger, Associate Director Regulatory Affairs, Vyteris (196 KB) Mon, 13 Apr 2009 12:43:40 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Development-and-Commercialization-of-Combination-Products-A-Drug-Eluting-Stent-Case-Study-TAXUS-E.aspxOctober 2004, by Kathleen M. Miller, Program Manager Drug Delivery, Boston Scientific (4.15 MB) Mon, 13 Apr 2009 12:42:06 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Development-and-Commercialization-of-Combination-Products-Update-Regulatory-Considerations-in-Appr.aspxOctober 2004, by Mark Kramer, Director Office of Combination Products, FDA" (175 KB)Mon, 13 Apr 2009 12:37:49 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Sterile-packaging-of-liquidpharmaceuticals--Using-rommelag-bottelpack-blow-fill-seal-machines.aspxMay 2004, by Mohammad Sadeghi, V.P. R&D Holopack International Corp. (2.9 MB)Mon, 13 Apr 2009 12:30:46 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/The-Evolution-of-a-New-Disposable-Filling-Technology-for-Sterile-Pharmaceuticals.aspxMay 2004, by Jim Furey, Product Manager Millipore Corporation (1,019 KB)Mon, 13 Apr 2009 12:05:42 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Corrective-and-Preventive-Actions-A-Five-Step-Approach_1.aspxFebruary 2004, Tonya White-Salters, AVECIA (213 KB) Mon, 13 Apr 2009 12:01:04 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Corrective-and-Preventive-Actions-A-Five-Step-Approach.aspxFebruary 2004, by Michael J Cross, BIOGEN IDEC (278 KB)Mon, 13 Apr 2009 11:58:58 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Disinfectant-Regulation-Technologies-Sterility-and-Validtion.aspxDecember 2003, by Jim Polarine, MA, STERIS (955 KB)Mon, 13 Apr 2009 11:57:41 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Approaching-Compliance-with-21-CFR-Part-11.aspxSeptember 2003, by Alexander Buck, FORMATECH (148 KB)Mon, 13 Apr 2009 11:50:04 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Presentations/Non-Destructive-Container-Closure-Integrity-Testing.aspxN/AThu, 12 Mar 2009 13:35:59 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1.aspxN/AMon, 13 Apr 2009 15:48:46 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/January-2010-Newsletter.aspxVol. 5 No. 1Fri, 12 Feb 2010 08:46:42 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/October-2009-Newsletter.aspxVol. 4 No. 3Fri, 02 Oct 2009 09:11:14 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/June-2009-Newsletter.aspxVol. 4 No. 2Wed, 10 Jun 2009 15:55:45 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/February-2009-Newsletter.aspxVol. 4 No. 1Tue, 03 Mar 2009 08:13:32 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/November-2008-Newsletter.aspxVol. 3 No. 4Tue, 14 Apr 2009 09:52:56 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/August-2008-Newsletter.aspxVol. 3 No. 3Tue, 14 Apr 2009 09:51:12 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/May-2008-Newsletter.aspxVol. 3 No. 2Mon, 13 Apr 2009 16:08:32 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/January-2008-Newsletter.aspxVol. 3 No. 1Mon, 13 Apr 2009 16:05:27 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/November-2007-Newsletter.aspxVol. 2 No. 4Mon, 13 Apr 2009 16:02:24 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/September-2007-Newsletter.aspxVol. 2 No. 3Mon, 13 Apr 2009 16:01:16 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/May-2007-Newsletter.aspxVol. 2 No. 2Mon, 13 Apr 2009 15:58:24 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-News_1/February-2007-Newsletter.aspxVol. 2 No. 1Mon, 13 Apr 2009 15:57:13 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Get-Involved.aspxN/ASun, 29 Mar 2009 12:24:04 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Sponsorship.aspxN/ASun, 29 Mar 2009 12:22:01 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Pictures.aspxN/AThu, 02 Jul 2009 14:19:59 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-Officers.aspxN/ASun, 29 Mar 2009 12:18:31 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-Resources_1.aspxN/ATue, 14 Apr 2009 10:02:20 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-Resources_1/Newsletter-Article-Submission-Policy-85-KB.aspxN/ATue, 14 Apr 2009 10:09:00 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-Resources_1/Newsletter-Advertising-Policy-81-KB.aspxN/ATue, 14 Apr 2009 10:13:58 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-Resources_1/Vendor-Sponsorship-Policy-24-KB.aspxThis lists what comes with sponsoring a dinner-meeting and includes a form to be submitted to the NEPDA to sponsor an event. Tue, 14 Apr 2009 10:14:52 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-Resources_1/Privacy-Policy-22-KB.aspxThis is how we protect our members' privacy.Tue, 14 Apr 2009 10:21:28 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-Resources_1/Event-Fee-Policy-23-KB.aspxThis is how we determine event fees and includes our cancellation policy.Tue, 14 Apr 2009 10:23:03 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-Resources_1/Speaker-Policy-84-KB.aspxThis is what we ask of our speakers and includes a form for the speaker to return to the NEPDA.Tue, 14 Apr 2009 10:24:01 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-Resources_1/Scholarship-Policy-127-KB.aspxGuidelines for providing scholarships to members of the NEPDA Student Chapter.Tue, 14 Apr 2009 10:24:57 GMThttp://www.pda.org/MainMenuCategory/Chapters/New-England/Chapter-Resources_1/Scholarship-Policies.aspxN/AFri, 27 Mar 2009 17:04:43 GMT