Call for Abstract
Scientific Program
2nd International Summit on GMP, GCP & Quality Control, will be organized around the theme “Ensuring the Quality standards of Manufacturing process”
GMP-2013 is comprised of 13 tracks and 88 sessions designed to offer comprehensive sessions that address current issues in GMP-2013.
Submit your abstract to any of the mentioned tracks. All related abstracts are accepted.
Register now for the conference by choosing an appropriate package suitable to you.
- Track 1-1FDA regulations and CFR
- Track 1-2EU-GMP guidelines
- Track 1-3WHO-GMP guidelines
- Track 1-4Roles of pharmaceutical inspection convention and co-operation scheme (PIC/S)
- Track 1-5Asia pacific: GMP regulations
- Track 1-6Regulatory approach in Latin America
- Track 1-7GMP in business implementation
- Track 1-8International regulatory affairs
- Track 2-1GMP for active pharmaceutical ingredients (API)
- Track 2-2Solid dosage forms
- Track 2-3Ophthalmic solutions
- Track 2-4Parenterals
- Track 2-5Topical solutions
- Track 2-6Recombinant DNA products and cellular therapeutic agents
- Track 2-7Licensing in pharmaceutical production
- Track 2-8Pharmaceutical excipients & packaging materials
- Track 3-1Design, monitoring, and control of manufacturing processes and facilities
- Track 3-2Quality by controlling the manufacturing operations
- Track 3-3Quality management systems
- Track 3-4Contamination, mix-ups, deviations, failures, and errors
- Track 3-5Processing methods, and testing procedures
- Track 3-6Facilities and equipments
- Track 3-7Employee training and management
- Track 3-8Role of qualified person and quality Indicators in GMP
- Track 4-1Role of ICH in designing GCP principles
- Track 4-2Institutional review boards and the informed consent process
- Track 4-3Post-approval regulatory requirements
- Track 4-4Requirements for current Good Clinical Practices (cGCP)
- Track 4-5Post-approval regulatory requirements
- Track 5-1Clinical trial & GLP regulations
- Track 5-2Ethical aspects in clinical trials
- Track 5-3GxP and 21 CFR part 11 and computer validation
- Track 5-4An insight to global advancements in Pre-Clinical & Clinical research
- Track 5-5Pre-clinical & clinical studies
- Track 5-6Case study reports and clinical documentation
- Track 5-7IEC-GCP regulations
- Track 5-8Principles of GLP in vitro Studies
- Track 5-9OECD guidelines for the testing of chemicals
- Track 6-1After-inspection process
- Track 6-2New developments in european medicines law
- Track 6-3Quality control - International reference materials
- Track 6-4Quality assurance - Inspection
- Track 6-5Inspection reports and errors
- Track 6-6Identifying and controlling critical quality attributes
- Track 6-7Quality improvement in human research protection programs
- Track 7-1Analytical quality control
- Track 7-2Corrective and preventative action (CAPA)
- Track 7-3Quality control - international reference materials
- Track 7-4Quality control in project management
- Track 7-5Quality assurance
- Track 7-6Total quality management
- Track 7-7Cleaning validation and process validation
- Track 7-8Analytical method validation and computer system validation
- Track 7-9Quality assurance Vs quality control
- Track 8-1Regulatory requirements
- Track 8-2Design controls
- Track 8-3Validation/qualification
- Track 8-4Regulatory audits
- Track 8-5CAPA and risk management
- Track 8-6Complaints handling or post marketing surveillance
- Track 9-1CMO selection and GMP compliance
- Track 9-2Technology transfer, relationship and project management
- Track 9-3Quality over quantity in contract manufacturing
- Track 9-4GMP in formulation development
- Track 9-5Socio economic impact on advanced technologies
- Track 10-1Implementation of computerized systems
- Track 10-2Suppliers, software developers, and quality management
- Track 10-3QMS and software standards attribute
- Track 10-4Computational validation and audits
- Track 10-5GAMP validation approach
- Track 10-6Principles of GLP & compliance monitoring
- Track 11-1Validation of HPLC methods in pharmaceutical analysis
- Track 11-2Analytical technologies for biopharmaceutical development
- Track 11-3Application of QBD and DOE in method development and validation
- Track 11-4Manufacturing process for therapeutic proteins
- Track 11-5Six sigma applications in method validation
- Track 12-1GMP concerns in the microbiology lab
- Track 12-2Sterility assurance, sterility testing and aseptic processes
- Track 12-3Microbial assays, limit detection and contamination control
- Track 12-4Cleaning, disinfection, and hygiene
- Track 12-5Validation of microbial recovery – Method suitability studies
- Track 12-6Quality control in a typical food processing system
- Track 12-7Food inspectorate, analytical services, and compliance unit
- Track 12-8Hazard analysis and critical control points (HACCP)
- Track 13-1Current CBER and CDER initiatives
- Track 13-2Bio- analytical methods and PAT
- Track 13-3Vaccine and antibody production
- Track 13-4GLP, GCP, and GAMP regulations