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Validation and Compliance

TITLE/AUTHOR PRICE
Active Pharmaceutical Ingredients: Developments, Manufacturing and Regulations (Nusim) 228.95
Analytical Chemistry in a GMP Environment (Miller) 174.00
Analytical Method Validation and Instrument Performance Verification (Chan/Lee/Lam/Zhang) 110.50
Calibration in the Pharmaceutical Laboratory (Kowalski) 298.95
Combination Products: Regulatory Challenges and Successful Product Development (Gopalaswamy) 138.95
Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry (Lopez) 228.95
Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics (Medina) 298.95
Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies (Wingate)548.95
Control of Particulate Matter Contamination in Healthcare Manufacturing (Barber) 295.95
Development and Evaluation of Drugs from Laboratory through Licensure to Market
2nd edition (Lee)
228.95
Encyclopedia of Pharmaceutical Technology, 3rd edition 6-Volume Set (Swarbrick) 3,495.00
Establishing a CGMP Laoratory Audit System: A Practical Guide (Bliesner) 92.95
Facility Validation: Theory, Practice, and Tools (Wrigley) 148.95
FDA Administrative Enforcement Manual (Parker) 198.95
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (Pisano and Mantus) 198.95
FDA-Speak: A Glossary and Agency Guide (Snyder) 228.95
Genetic Testing: Care Consent and Liability (Sharpe) 100.95
Global Pharmaceutical Marketing: A Practical Guide to Codes and Compliance (Grice) 234.00
Global Regulatory Issues for the Cosmetics Industry (Betton) 129.00
GLP Essentials: A Concise Guide to Good Laboratory Practice 2nd edition (Anderson) 59.95
GLP Quality Audit Manual 3rd edition (Anderson) 298.95
GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers Volume 1 6th edition (Steinborn) 398.95
GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers Volume 2 6th edition (Steinborn) 328.95
GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers 6th edition • 2 Volume Set (Steinborn) 698.95
Good Laboratory Practice, 2nd edition (Seiler) 198.00
Good Laboratory Practice Regulations, 4th edition (Weinberg) 228.95
Good Manufacturing Practices for Pharmaceuticals 6th edition (Nally) 248.95
Good Pharmaceutical Manufacturing Practice: Rationale and Compliance (Sharp) 298.95
Handbook of Biogeneric Therapeutic Proteins: Regulatory Manufacturing Testing and Patent Issues (Niazi) 248.95
Handbook of Microbiological Quality Control Pharmaceuticals and Medical Devices (Baird) 178.95
Handbook of SOPs for Good Clinical Practice 2nd edition (Clive) 298.95
How to Develop and Manage Qualification Protocols for FDA Compliance (Cloud) 348.95
In Silico Technologies in Drug Target Identification and Validation (Leon) 148.95
International Biotechnology, Bulk Chemical, and Pharmaceutical GMPs, 5th edition (Anisfeld) 378.95
International Labeling Requirement for Medical Devices, Equipment and Diagnostic Products 2nd edition (Sidebottom) 348.95
ISO 9001: 2000 for Small Business (Gaal) 118.95
ISO 9001: 2000 Document Development Compliance Manual (Haider) 288.95
Laboratory Auditing for Quality and Regulatory Compliance (Singer) 228.95
Method Validation in Pharmaceutical Analysis: A Guide to Best Practice (Ermer and Miller) 240.00
New Drug Approval Process 4th edition (Guarino) 248.95
New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics (Sahajwalla) 228.95
Patent Intelligence and Technology Report 2006 574.00
Patent Peace of Mind (Paul) 524.00
Pharmaceutical and Medical Device Validation by Experimental Design (Torbeck) 228.95
Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook (Cloud) 298.95
Pharmaceutical Manufacturing Handbook: Regulations and Quality (Gad) 194.00
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance (Haider) 228.95
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, 2nd edition (Hynes) 228.95
Pharmaceutical Process Validation (Nash and Wachter) 298.95
Pharmaceutical Quality Systems (Schmidt) 248.95
The Pharmaceutical Regulatory Process (Berry) 248.95
Pharmacovigilance (Mann) 354.00
Principles and Practice of Pharmaceutical Medicine, 2nd edition (Edwards) 249.00
Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices and Industrial Case Studies (Rathore) 228.95
The QC Laboratory Chemist (Nilsen) 198.95
Quality Assurance in Analytical Chemistry: Training and Teaching with CD-ROM (Wenclawiak, Koch, and Hadjicostas) 79.00
Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 75.00
Software Development and Quality Assurance for the Healthcare Manufacturing Industries 3rd edition (Mallory) 298.95
Software Quality Assurance SOPs for Healthcare Manufacturers 2nd edition (Mallory) 248.95
Statistical Aspects of BSE and vCJD (Donnelly and Ferguson) 78.95
Statistical Thinking for Non-Statisticians in Drug Regulation (Kay) 79.00
Strauss' Federal Drug Laws and Examination Review 5th edition 78.95
Testing Computers Systems for FDA/MCA Compliance (Stokes) 198.95
Validated Cleaning Technologies for Pharmaceutical Manufacturing (LeBlanc) 248.95
Validating Chromatographic Methods: A Practical Guide (Bliesner) 83.95
Validating Corporate Computer Systems (Wingate) 298.95
Validating Medical Packaging (Pilchik) 188.95
Validation and Qualification in Analytical Laboratories, 2nd edition (Huber) 249.95
Validation of Active Pharmaceutical Ingredients 2nd edition (Berry) 328.95
Validation of Cell-Based Assays in the GLP Setting: A Practical Guide (Prabhakar) 149.00
Validation of Pharmaceutical Processes, 3rd edition (Agalloco)328.95
Validation Standard Operating Procedures Book + CD-ROM, 2nd edition (Haider) 298.95
Write It Down: Guidance for Preparing Effective and Compliant Documentation, 2nd edition (Gough) 248.95
Prices subject to change - Prices are in U.S. Dollars

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