Compliance handbook for pharmaceuticals, medical devices, and biologics. (©2004)

• Record Type: Book
• Further Information: Note: Edited by Carmen Medina.
• Other Names: Medina, Carmen
• Contents: Preface; Introduction; Contents; Contributors; Regulatory Submissions; Compliance Requirements During the Drug Development Process; Validation: A New Perspective; Validating Analytical Methods for Pharmaceutical Applications: A Comprehensive Approach; The StabilityTesting Program; Computer Validation: A Compliance Focus; Compliance Issues Associated with Cleaning in the Pharmaceutical Industry; The Batch Record: A Blueprint for Quality and Compliance; Change Management: A Far-Reaching, Comprehensive, and Integrated System; The Vendor Qualification Program.
• Publisher Details: New York : Marcel Dekker
• Publication Date: 2004
• Copyright Date: 2004
• Extent: 1 online resource (xviii, 666 pages), illustrations
• Subjects: 615.190685; Pharmaceutical industry -- Quality control; Drugs -- Standards -- United States; Drug Industry -- standards; Biological Agents -- standards; Equipment and Supplies -- standards; Guideline Adherence -- organization & administration; Pharmaceutical Preparations -- standards; Quality Control; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Drugs -- Standards; Pharmaceutical industry -- Quality control; United States; United States; Electronic books
• Languages: English
• ISBNs: 0824758749; 9780824758745; 0203026969; 9780203026960; 9780824740788; 0824740785
• Related ISBNs: 0824740785
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.