Source: http://www.fdacompliancespecialists.com/supplier-quality-audits.php
Timestamp: 2019-02-18 14:11:17
Document Index: 180844931

Matched Legal Cases: ['art 210', 'art 211', 'art 11', 'art 820', 'art 4', 'art 50', 'art 54', 'art 56']

Global GxP Drug and Medical Device Supplier Quality Audits - fdacompliancespecialists.com
(Pharmaceutical, Medical Device, and Biotechnology Industries)
Supply chain globalization is a continuous challenge and many regulated companies must manage an increasingly challenging and demanding internal and/or supplier audit program without adequate resources. Outsource our highly experienced auditors today!
Fully qualified auditors experienced with regulations and standards:
(e.g. ISO 9001, ISO 13485, ISO 14971, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 11, EU Directive 2003/94/EC, Health Canada Food and Drug Regulations, 21 CFR Part 820, 21 CFR Part 4, EU MDD 93/42/EEC [amended 2007/47/EC], EU Annex 11, SOR/98/282, Japan’s PMD Act, ICH Q6A, ICH Q9, ICH Q10, 21 CFR Part 50, 21 CFR Part 54, 21 CFR Part 56, ICH E6, ICH E2A, ICH E8, PIC/S PE009-11, and GAMP).
We provide high-caliber, FDA Compliance Specialists with 15+ years of regulated industry auditing experience; we provide a cost-effective, budget friendly, fixed price audit for each audit we support; our fixed price audit includes: pre-audit preparation; audit planning; travel time (U.S. only); the audit itself; daily audit debriefs; the final audit report with one review cycle; and to complement our professional auditing services, we assign a dedicated U.S. based audit administrator for every audit we support.