http://www.pda.org/MainMenuCategory/Chapters/Metro.aspxThe PDA Metro Chapter serves the New Jersey, New York and Philadelphia Tri-State area as an extension of PDA International. The local chapter focuses its efforts towards organizing and providing local events targeted at scientists involved in the development, manufacture, quality control and regulatory affairs for pharmaceuticals and related products.Copyright 2008en-usFri, 30 Jul 2010 23:57:09 GMT1http://www.pda.org/MainMenuCategory/Chapters/Metro/About-Us.aspxN/ASun, 29 Mar 2009 11:52:29 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration.aspx?ET=Chapter&R=&M=&Y=&Q=&C=0&SO=StartDate%20ASC&CH=25659N/ATue, 09 Jun 2009 15:20:20 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Upcoming-Events.aspxN/ASun, 29 Mar 2009 11:51:48 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Upcoming-Events/5th-Annual-Metro-Chapter-Day-Symposium-Flyer.aspxN/AWed, 24 Feb 2010 10:18:42 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Upcoming-Events/5th-Annual-PDA-Metro-Chapter-Day-Symposium.aspxFeaturing Jim Agalloco, Ellen Moskowitz, Kelli Dobilas, Robert Seltzer, Joel Schwartzman, and Radhakrishna S. Tirumalai. Last day to register is April 2, 2010.Wed, 24 Feb 2010 09:52:58 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Upcoming-Events/Standardizing-Sterility-Risk-Assessments.aspxGloria Berrios of Eli Lilly & Co. will share how sterility assurance risk management was recently revamped at Lilly's parenteral manufacturing facility in Indianapolis and benchmark how the Lilly program compares to similar programs conducted at other firms.Tue, 02 Feb 2010 08:28:06 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Upcoming-Events/January-14-2010-event-flyer.aspxN/ATue, 22 Dec 2009 10:18:24 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Upcoming-Events/IMPURITIES-IN-DRUG-SUBSTANCE-AND-DRUG-PRODUCT.aspxImpurities in drug products frequently are the cause of side effects and must be controlled. This talk will define impurities and impurity profiles in both drug products and drug substances, discuss impurity limits then discuss the difference in older products of USP testing versus impurity profile testing. The ICH classification of impurities and analytical methods for impurity detection will be followed by discussion of the difficulty in detecting low levels of adventitious contamination as well as the deliberate contamination of products such as glycerine and heparin.Tue, 22 Dec 2009 09:44:25 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Upcoming-Events/STERILE-PROCESS-TECHNOLOGY-NEW-FACILITY-TOUR.aspxJohnson & Johnson recently completed their state of the art Sterile Process Technology (SPT) center in Raritan, NJ. REGISTRATION IS LIMITED TO THE FIRST 75 Fri, 13 Nov 2009 11:30:45 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Upcoming-Events/Vendor-Show-FDA-Presentation.aspx"State of the Industry in the New Jersey District"Mon, 31 Aug 2009 09:35:52 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations.aspxN/ASun, 29 Mar 2009 11:51:16 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Microbiology-Best-Laboratory-Practices.aspxXiaoming Wang, April 6, 2010Tue, 13 Apr 2010 11:49:31 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Current-Trends-in-Process-Validation-The-New-Paradigm.aspxEllen Moskowitz, April 6, 2010Tue, 13 Apr 2010 11:47:02 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Preliminary-Audit-to-a-Pre-Approval-Inspection.aspxRobert D. Seltzer, April 6, 2010Tue, 13 Apr 2010 11:45:08 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/483s-Not-Here.aspxJoel Schwartzman, April 6, 2010Tue, 13 Apr 2010 11:43:22 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/USP-Activities-Impacting-Sterilization-Sterility-Assurance.aspxJames Agalloco, April 6, 2010Tue, 13 Apr 2010 11:41:01 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Overview-of-Pre-Approval-Inspections.aspxKelli F. Dobilas, April 6, 2010Tue, 13 Apr 2010 11:35:00 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/STATE-OF-THE-PHARMACEUTICAL-INDUSTRY.aspxPresented October 1, 2009 at the PDA Metro Chapter Vendor Show & FDA NightFri, 02 Oct 2009 14:58:12 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/GMPs-for-the-21st-Century-A-Risk-Based-Approach.aspxN/AWed, 01 Jul 2009 14:30:35 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Risk-Based-Validation-and-Requalification-of-Processes-Equipment.aspxN/AWed, 01 Jul 2009 14:28:14 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/A-Risk-Based-Model-for-Choosing-in-Process-Testing-Sites.aspxN/AWed, 01 Jul 2009 14:25:36 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Assessing-the-Risk-of-Objectionable-Microorganisms_1.aspxN/AWed, 01 Jul 2009 14:23:04 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Assessing-the-Risk-of-Objectionable-Microorganisms.aspxN/AWed, 01 Jul 2009 14:16:56 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Using-Risk-Management-To-Put-the-Design-in-QbD.aspxN/AWed, 01 Jul 2009 13:40:51 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Team-Biologics-Inspection-Approach.aspxAnne Marie Montemurro, May 2009 (159 KB)Fri, 29 May 2009 14:18:59 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Canadian-Pharmaceutical-GMP-Richard-Pike-184-KB-.aspxN/AMon, 13 Apr 2009 10:23:44 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Cold-Chain-Shipping--Protecting-Temperature-Sensitive-Products-Diane-McLean-102-MB.aspxN/AMon, 13 Apr 2009 10:22:40 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/Disaster-Recovery-Business-Continuity--related-but-NOT-the-Same-Teri-Stokes-PhD-699-KB.aspxN/AMon, 13 Apr 2009 10:21:40 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/End-User-Testing-for-Performance-Qualification-of-GXP-Part-11-Systems--Off-the-Shelf-OTS-Teri-St.aspxN/AMon, 13 Apr 2009 10:20:43 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/FDA-API-Inspections-Robert-Horan-PhD-500-KB-.aspxN/AMon, 13 Apr 2009 10:19:48 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Presentations/FDA-Inspectional-Approach-Paul-Bellamy-733-KB-.aspxN/AMon, 13 Apr 2009 10:16:29 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1.aspxN/AMon, 17 Aug 2009 15:05:47 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/PDA-Metro-Newsletter-3.aspxVolume 2, No. 2 June 2010Thu, 17 Jun 2010 11:48:33 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/Article-2-Qualification-of-Impurities-in-Drug-Substances-and-Drug-Products-.aspxN/AThu, 17 Jun 2010 11:24:12 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/Article-1-GLOBAL-STABILITY-PROGRAM-.aspxN/AThu, 17 Jun 2010 11:18:12 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/PDA-Metro-Chapter-Newsletter_1.aspxVolume 2, Number 1 January 2010Thu, 28 Jan 2010 12:17:38 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/FDA-Finalizes-QbD-Guidance--Its-Time-to-Get-Moving-art-3-January-2010.aspxN/ATue, 26 Jan 2010 12:36:19 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/Variability-in-the-Bacterial-Endotoxins-Test-art-2-January-2010.aspxN/ATue, 26 Jan 2010 12:34:42 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/Environmental-Monitoring-for-Nonsterile-Manufacturing-art-1-January-2010.aspxN/ATue, 26 Jan 2010 12:31:49 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/Photo-Gallery.aspxN/ATue, 25 Aug 2009 11:43:42 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/Job-Board.aspxN/ATue, 25 Aug 2009 11:41:25 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/Calendar-of-Events.aspxN/ATue, 25 Aug 2009 11:39:13 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/Article-3-Global-Compendium.aspxN/ATue, 25 Aug 2009 11:27:15 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/James-Agalloco-Article.aspxN/AFri, 21 Aug 2009 09:23:38 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/Auditing-API-Facilities.aspxN/AFri, 21 Aug 2009 09:15:23 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/Presidents-Corner--September.aspxN/AFri, 21 Aug 2009 08:56:05 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-News_1/PDA-Metro-Chapter-Newsletter.aspxVolume 1, number 1 September 2009Mon, 17 Aug 2009 15:11:12 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Get-Involved.aspxN/ASun, 29 Mar 2009 11:48:43 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Sponsorship.aspxN/ASun, 29 Mar 2009 11:47:15 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Pictures.aspxN/AThu, 02 Jul 2009 14:29:58 GMThttp://www.pda.org/MainMenuCategory/Chapters/Metro/Chapter-Officers.aspxN/ASun, 29 Mar 2009 11:46:15 GMT