GOOD MANUFACTURING PRACTICES - GMP - FOR
VETERINARY AND PHARMACEUTICAL PRODUCTS ACCORDING TO FDA
STANDARDS
OBJECTIVE
Present concepts of Quality Assurance Systems based on FDA
guidelines. Discuss the most important aspects observed by
auditors from FDA and other international agencies.
DIRECTED TO:
Quality managers and supervisers, production sponsors and
for all that are involved in maintaining the highest
standards of CGMP in their Quality Assurance Systems
PROGRAMM
1. QUALITY ASSURANCE SYSTEMS
2. GMP ( GOOD MANUFACTURING PRACTICES )
Quality assurance system based on FDA Guidelines,
covering all the activities of companies relative to quality
aspects
3. IMPORTANT ASPECTS OF GMP
Quality Assurance Manual, SOP's, Validation protocols
and reports, OOS, MOC, Traceability, Audits, DMF and
Site MF . Case studies
4. AUDITING A QUALITY ASSURANCE SYSTEM - GMP
Important aspects discussed with international auditors.
SALVI ENGENHARIA - TREINAMENTO E CONSULTORIA
Rua Américo de Campos 1025 - C. Universitária-Campinas- SP.
Fone/Fax:(0xx19)3287-7533
e-mail -
salvieng@uol.com.br
home-page -
www.salvieng.com.br
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