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3^rd International Summit on GMP, GCP & Quality Control, will be organized around the theme "Manufacturing and Quality Guidelines; Training and Beyond".

GMP Summit-2014 is comprised of 15 sessions designed to offer comprehensive sessions that address current issues in Journal of Developing Drugs.

Submit your abstract to any of the following tracks. All related abstracts are accepted.

Sessions

Good Manufacturing Practices: The Gap within

Facts About Current Good Manufacturing Practices (cGMPs), Good Automated Manufacturing Practice (GAMP), Current Trends in the FDA's Enforcement of GMP Requirements, GMP/GCP Interface, GMP audits etc.

Current Regulations and Quality Standards

FDA regulations and CFR, EU-GMP guidelines, WHO-GMP guidelines, Roles of PIC/S, Asia pacific: GMP regulations, Regulatory approach in Latin America, International Regulatory Affairs etc.

Current GMP Guidelines (cGMP)

GMP for active pharmaceutical ingredients (API), Solid dosage forms, Ophthalmic solutions, Parenterals, Topical solutions, Combination products, Recombinant DNA products, Cellular therapeutic agents, Licensing in pharmaceutical production, Pharmaceutical excipients and Packaging materials etc.

The Role of "C" in cGMP

Design, monitoring, and control of manufacturing processes and facilities, Maintenance, calibration and validation of equipment, Condition of facilities, Qualifications and training of employees, Reliability and reproducibility of processes, Test method validation, Handling of complaints etc.

Good Clinical Practices & Good Laboratory Practices

GMP from Phase 1 to Phase 3, The Principles of ICH GCP, Clinical trial protocol, Clinical trial & GLP regulations, Ethical aspects in clinical trials, Principles of GLP in vitro Studies, OECD guidelines etc.

Quality Assurance

Quality Risk Management, Quality Metrics, Data integrity issues, Lean Manufacturing without Compromising Quality, Quality inspection and Auditing, Quality by Design(QbD), The role of pharmacist in Quality Improvement and CQI etc.

Quality Control

Control of the raw materials, Analytical quality control, Drug product stability testing, Method transfer, Corrective and preventative action (CAPA), Quality control in project management, Compliance (FDA, MHRA, ICH, USP, BP, EP, JP), Process Analytical Technology etc.

Validation

Change Control, Equipment validation, Facilities validation, HVAC system validation, Cleaning validation, Process validation, Analytical method validation, Computer system validation, Phases of Validation etc.

Contract Manufacturing

Traditional role of contract manufacturing, Pharmaceutical industry changes and future needs, Future role of CMOs, Requirements for successful contract manufacturing partnerships, Outsourcing Trends, Managing Virtual Manufacturing etc.

Sterile/Aseptic Manufacturing

Lean manufacturing, Six sigma approaches, Method development, transfer & validation, Clean rooms and Barrier systems, Microbiological basics, Training Requirements, Sterilization processes, Environmental monitoring, Media fills etc.

GMP in Microbiology and Biotechnology

Sterility assurance, Sterility testing, Aseptic processes, Microbial assays, Limit detection, Contamination control, Cleaning, disinfection, and hygiene, Validation of microbial recovery, FDA 510k Testing etc.

GMP in Food Industry

Cleaning, Disinfection, Hygiene, Food inspectorate, Analytical services, Compliance unit, Hazard analysis and critical control points (HACCP), Quality control in a typical food processing system etc.

Medical Devices

Regulatory requirements, Design controls, Validation/qualification, Regulatory audits CAPA and risk management, Complaints handling or post marketing surveillance, Quality by Design (QbD) etc.

Computational Strategies in GMP/GCP

Implementation of computerized systems, Suppliers, software developers, and quality management, QMS and software standards attribute, computational validation and audits, GAMP validation approach, Principles of GLP & compliance monitoring etc.

Storage, Distribution, Transportation

Cold chain storage, Supply chain integrity, Good Distribution Practices, Manufacturing Execution System (MES), New GDP guidelines, Distribution management, Data-Driven approaches to Ensure the Quality of pharmaceuticals in distribution etc.