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Thursday, December 23, 2010

Happy Holidays

Happy Holidays!

Written by QPharma at 11:15 AM

Labels: Regulatory Compliance, Validation

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Who is QPharma? And why are we blogging?

QPharma: Morristown, NJ, United States; Founded in 1994, QPharma delivers a suite of professional services that spans the product development lifecycle, from quality and validation solutions to Prescription Drug Marketing Act and Fulfillment services. We serve the Pharmaceutical, Biotechnology, Medical Device, Animal Health, Cosmetic, and Blood/Tissue industries. ...and we are blogging so that our Subject Matter Experts can keep you up-to-date with all of the latest news and excitement taking place in our industry, and for our friends, colleagues, and clients to have a say in that news.

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What we're talking about

FDA Regulatory Compliance Validation QPharma 21 CFR Part 11 Quality Management Medical Device Approved Vendors Audits GMPs Project Management Software Validation Training 21 CFR 820 Alexis Stroud Bruce Fieggen Center for Devices and Radiological Health (CDRH) Class III Healthcare Reform Nancy Tomoney Patient Protection and Affordable Care Act Process Validation Risk Assessments The Twelve Towers pharmaceuticals prescription drugs 510K 905(j) Aggregate Spend Biopharming Center for Drug Evaluation and Research Computer System Validation (CSV) Consent Decree Electronic Signatures Frankenfish Healthcare Johnson and Johnson McNeil Life Sciences Obama PDMA Physician Payment Sunshine Provision Physician Reporting Project Management Novel Quality Systems Sampling Software as a Service (SaaS) Transgenic cigarettes clearance drugs iCertify medical devices notification premarket report state law reporting state law updates submission tobacco tobacco act 21 CFR 21 CFR 211 21 CFR Part 201 21 GFR 211 APHIS Alliance for a Stronger FDA Alternative Sampling Application BIOCOM Best Practices Biometric Biosafety CBER CDRH CRM Cheryl Eckerd Class I Class II Cloud Computing Computerized System Lifecycle Congress Consultants Consumer Healthcare Custom Databases DS DTC Data Data Privacy Document Dr. Jeff Shuren Drug Safety and Accountability Act EMEA EPA Edible Vaccines Electronic Records Electroporation Equipment FAT FDA’s 21st Century Initiative FIFRA FQPA FRS Federal Budget Fiscal Year Form 483 Fred Sperry Fulfillment GAMP 5 GAP Analyses. Audits GLPs Generic Tamiflu Genetic Engineering Genetic Testing Genetically Engineered Genzyme GlaxoSmithKline Good Automated Manufacturing Practice Good Business Practices Guidance HBA Healthcare Reform Act IQ ISPE Annual Meeting IVD IVT Validation Week Jack Kingston Jeff Boatman LDT LIMS LabWare Laboratories MDDS Managing Manufacturing Control Systems Massachusetts Reporting Requirements MedWatch Medical Device Data Systems Mergers and Acquisitions Michael Bennet Monitoring Non-Biometric OQ OTC Off-Label Promotion PAP PCID PQ Part11 Patient Assistance Program Pharmaceutical Marketing Disclosure Law Pharming Plantibodies Plantigens Premarket Approval Program Integrity Project Charter Public Health RAPS Annual Meeting RFP Recalls Representative Licensing Republicans Risk Based Validation Robert Finamore SAT Safe Medical Device Act Sample Accountability Section 6002 Stakeholders Standard Operating Procedures State Healthcare Law Static Data Planning Stem Cells System Development Life Cycle Systems TSCA Test Kits Test Management Tools Traceability Matrix TrackWise Transgenics URS USEPA VIPPS Validation Life Cycle Vermont WOTY Warning Letters Woman of the year Workflows classification counterfeit e-Learning e-sigs healthcare businesswomen's association internet laboratory manufacturers medication medications online penicillin regualtory compliance regulations rising star smoking tasks whistleblower

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