Call for Abstract

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