BioTechLogic at BioPharm America in San Francisco
BIOTECHLOGIC HEADS TO BIOPHARM AMERICA IN SAN FRANCISCO CA, SEPT. 16TH – 18TH (8/19/2009) Are you heading to BioPharm America? Partnering has opened and we want to hear from you. BioTechLogic, Inc. is...
View ArticleBioTechLogic participates on Bio Program Committee
JULIE TRAJKOSKI, SENIOR MANAGER OF OPERATIONS, FOR BIOTECHLOGIC, INC. INVITED TO PARTICIPATE ON THE 2010/2011 BIO PROGRAM COMMITTEE(8/24/2009) Julie Trajkoski, Senior Manager, Operations for...
View ArticleBrief from PDA workshop on FDA Guidance for Process Validation
BRIEF FROM THE PDA WORKSHOP ON FDA’S NEW GUIDANCE ON PROCESS VALIDATION “THE SHIFTING PARADIGM IN PROCESS VALIDATION” OCTOBER 26-27, 2009 (10/31/2009) Background: The FDA’s Draft Guidance on Process...
View ArticleBioTechLogic exhibits at IBC’s 13th International Process Validation Exhibition
BIOTECHLOGIC TO EXHIBIT AT IBC’S 13TH INTERNATIONAL PROCESS VALIDATION FOR BIOPHARMACEUTICALS CONFERENCE & EXHIBITION 2009 IN LA COSTA, CALIFORNIA (12/18/2008) BioTechLogic will be exhibiting at...
View ArticleBioTechLogic speaks at 2011 PDA/FDA Process Validation Guidance Workshop
BIOTECHLOGIC INVITED TO SPEAK ON PANEL 2011 PDA/FDA Process Validation Guidance Workshop: Aoril 13-14, 2011 JW Marriott San Antonio Hill Country Resort & Spa San Antonio, TX,...
View ArticleMedical Device Process Validation
Medical Device Quality Systems Manual Medical Device Process Validation Quality Management Systems – Process Validation Guidance The Global Harmonization Task Force (2004) The post Medical Device...
View ArticleGlobal Process Validation Guidance
FDA Guideline On General Principles Of Process Validation (1987) WHO Supplementary Training Modules: Validation, Water, Air Handling Systems FDA’s Draft Process Validation Guidance (2008) EMEA Process...
View ArticleUS Regulatory References
FDA – U.S. Food and Drug Administration Guidance, Complaince: Regulatory Information (Biologics) US BIOLOGIC REGULATIONS The final regulations published in the Federal Register (daily published record...
View ArticleGlobal Good Manufacturing Practices
US GMPS Background: Overview of US GMPs for Active Pharmaceutical Ingredients (API) References: Code of Federal Regulations (US GMP’s) 21 CFR 58 – Good Labratory Practices for Non-Clinical Laboratory...
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EU Regulatory References
EMA–European Medicines Agency EMA Quality Guidelines EMA Biologic Guidelines EudraLex – Volume 3 Scientific guidelines for medicinal products for human use EudraLex – Volume 4 Good manufacturing...
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