Current Regulations and Quality Standards
Roles of pharmaceutical inspection convention and co-operation scheme (PIC/S) are to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry. The FDA regulations and CFR are responsible for protecting and promoting public health through the regulation and supervision of all the products available in the market to ensure patient compliance. EU-GMP guidelines are needed to maintain the products quality which is stricter when compared to WHO-GMP guidelines.
- Roles of pharmaceutical inspection convention and co-operation scheme (PIC/S)
- FDA-GMP regulations and CFR
- EU-GMP regulations (European union-GMP regulations)
- Canadian GMP regulations
- Japan GMP regulations
- International regulatory affairs
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Current Regulations and Quality Standards 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
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- Regulatory Communications and Submissions
- Regulatory Requirements for Pharmaceuticals
- Softwares in GMP and GCP
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