FDA
US FDA Pharma GMP 21 CFR 211
Esta certificación beneficiará a los fabricantes de productos sujetos a ls requerimientos regulatorios de FDA para evitar “findings” en las inspecciones de la citada Agencia. Excelente cualificación para los profesionales de Quality Asurance, Manufacturing, Regulatory Affairs, Supplier Quality and Quality Control de empresas dedicadas a la fabricación de productos farmacéuticos.
Nuestro director es:
José Rodríguez
Nuestro director es:
Biólogo y doctor en Inmunología por la Universidad de Granada. Es Presidente y CEO de Business Excellence Consulting (BEC), empresa de consultoría y formación en Regulatory compliance, Risk management y Operational Excellence en los sectores regulados por la FDA.
Carretera de Fuencarral, Km 22 Edificio Net-Pharma 28108 Alcobendas (Madrid)
Programa
Opening Remarks
U.S. FDA Overview
FDA Laws and Regulations
FDA Guides and Guidances
21 CFR Part 211
Subpart A-General Provisions
211.1 – Scope
Subpart B-Organization and Personnel
211.22 – Responsibilities of quality control unit
211.25 – Personnel qualifications
211.28 – Personnel responsibilities
211.34 – Consultants.
Subpart C-Buildings and Facilities
211.42 – Design and construction features
211.44 – Lighting
211.46 – Ventilation, air filtration, air heating and cooling
211.48 – Plumbing
211.50 – Sewage and refuse
211.52 – Washing and toilet facilities
211.56 – Sanitation
211.58 – Maintenance
Subpart D-Equipment
211.63 – Equipment design, size, and location
211.65 – Equipment construction
211.67 – Equipment cleaning and maintenance
211.68 – Automatic, mechanical, and electronic equipment
211.72 – Filters
Subpart E-Control of Components and Drug Product Containers and Closures
211.80 – General requirements
211.82 – Receipt and storage of untested components, drug product containers, and closures
211.84 – Testing and approval or rejection of components, drug product containers, and closures
211.86 – Use of approved components, drug product containers, and closures
211.87 – Retesting of approved components, drug product containers, and closures
211.89 – Rejected components, drug product containers, and closures
211.94 – Drug product containers and closures
Subpart F-Production and Process Controls
211.100 – Written procedures; deviations
211.101 – Charge-in of components
211.103 – Calculation of yield
211.105 – Equipment identification
211.110 – Sampling and testing of in-process materials and drug products
211.111 – Time limitations on production
211.113 – Control of microbiological contamination
211.115 – Reprocessing
Subpart G-Packaging and Labeling Control
211.122 – Materials examination and usage criteria
211.125 – Labeling issuance
211.130 – Packaging and labeling operations
211.132 – Tamper-evident packaging requirements for over-the-counter (OTC) human drug products
211.134 – Drug product inspection
211.137 – Expiration dating
Subpart H-Holding and Distribution
211.142 – Warehousing procedures
211.150 – Distribution procedures
Subpart I-Laboratory Controls
211.160 – General requirements
211.165 – Testing and release for distribution
211.166 – Stability testing
211.167 – Special testing requirements
211.170 – Reserve samples
211.173 – Laboratory animals
211.176 – Penicillin contamination
Subpart J-Records and Reports
211.180 – General requirements
211.182 – Equipment cleaning and use log
211.184 – Component, drug product container, closure, and labeling records
211.186 – Master production and control records
211.188 – Batch production and control records
211.192 – Production record review
211.194 – Laboratory records
211.196 – Distribution records
211.198 – Complaint files
Subpart K-Returned and Salvaged Drug Products
211.204 – Returned drug products
211.208 – Drug product salvaging
Profesores
José (Pepe) Rodríguez
Biólogo y doctor en Inmunología por la Universidad de Granada. Es Presidente y CEO de Business Excellence Consulting (BEC), empresa de consultoría y formación en Regulatory compliance, Risk management y Operational Excellence en los sectores regulados por la FDA. BEC Spain es una empresa filial en España de BEC.
Entre 2009 y 2011 fue Science Advisor para la U.S. FDA en el distrito de San Juan (Puerto Rico).
Está certificado como Quality Manager, Quality Engineer, Quality Auditor, Quality HACCP Auditor, Biomedical Auditor, Six Sigma Black Belt, and GMP Professional por la American Society of Quality (ASQ). Miembro y Presidente de la ASQ en Puerto Rico entre 2003 y 2005. Es miembro de RAPS, AAMI, y PDA.
Es autor de los siguientes libros:
- CAPA for the fda regulated industry (2010)
- Quality risk management in the fda regulated industry (2012)
- The fda and worldwide current good manufacturing practices and quality system requirements guidebook for finished pharmaceuticals (2014)
- Handbook of investigation and effective capa systems (2016)