Good Manufacturing Practices: The Gap Within
Good Manufacturing Practice is the part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. Good Manufacturing practices conference aims at both production and Quality Control. Current Good Manufacturing Practices (cGMP) is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. FDA regulates the quality of pharmaceuticals very carefully. Current Trends in the FDA is the main regulatory standard for ensuring pharmaceutical quality.
- Facts about current good manufacturing practices (cGMPs)
- Good automated manufacturing practice (GAMP)
- FDA good manufacturing practices
- GMP/GCP interface & GMP audits
- GMPs for OTC and cosmetic products – global requirements
- GMPs for medical devices
- GMP requirements & standards
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Good Manufacturing Practices: The Gap Within Conference Speakers
Recommended Sessions
- Pharmaceutical Audit
- Auditing Deviations, Product Complaints, and CAPA Systems
- Best Industry Practices
- Biologics & Biosimilars
- Clinical Affairs & Regulatory Strategies
- Contract and Sterile/Aseptic Manufacturing
- Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals
- Current Regulations and Quality Standards
- Excipient Qualification and Supply Chain Controls
- Formulation Development
- Global Regulatory Intelligence
- GMP in Food Industry, Microbiology & Biotechnology
- Good Clinical Practices and Good Laboratory Practices
- Good Manufacturing Practices: The Gap Within
- Impact of Brexit on Regulatory Framework
- Intellectual Property Rights
- Medical Device & Combination Products Regulations
- Penalties for Regulatory Non-compliance
- Quality Control & Quality Assurance
- Quality Management System in Testing Laboratories
- Regulatory Affairs
- Regulatory Challenges for Medical Devices
- Regulatory Communications and Submissions
- Regulatory Requirements for Pharmaceuticals
- Softwares in GMP and GCP
- Storage, Distribution, Transportation
- Validation
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