Call for Abstract
6th International Conference and Exhibition on GMP, GCP & Quality Control, will be organized around the theme “Manufacturing and Quality Guidelines: Its Importance Creates its Need!”
GMP Summit 2017 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in GMP Summit 2017
Submit your abstract to any of the mentioned tracks.
Register now for the conference by choosing an appropriate package suitable to you.
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 QC. 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.
- Track 1-1Facts about current good manufacturing practices (cGMPs)
- Track 1-2Good automated manufacturing practice (GAMP)
- Track 1-3FDA good manufacturing practices
- Track 1-4GMP/GCP interface & GMP audits
- Track 1-5GMPs for OTC and cosmetic products – global requirements
- Track 1-6GMPs for medical devices
- Track 1-7GMP requirements & 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 quality which is stricter when compared to WHO-GMP guidelines.
- Track 2-1Roles of pharmaceutical inspection convention and co-operation scheme (PIC/S)
- Track 2-2FDA-GMP regulations and CFR
- Track 2-3EU-GMP regulations (European union-GMP regulations)
- Track 2-4Canadian GMP regulations
- Track 2-5Japan GMP regulations
- Track 2-6International regulatory affairs
- Track 2-7Imporatnce of audit in pharmaceutical industry
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US FDA. cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
- Track 3-1EU-GMP guidelines (European union-GMP guidelines)
- Track 3-2WHO-GMP guidelines (World health organization-GMP guidelines)
- Track 3-3GMP for active pharmaceutical products
- Track 3-4GMP for biopharmaceuticals
- Track 3-5cGMP quality principles for biologics and biotechnological products
- Track 3-6Licensing in pharmaceutical production & GMP documentation
The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.
- Track 4-1Design, monitoring, and control of manufacturing processes and facilities
- Track 4-2Maintenance, calibration and validation of equipment
- Track 4-3Role of qualified person and quality Indicators in GMP
- Track 4-4Reliability and reproducibility of processes
- Track 4-5Quality management systems
The role of ICH in designing GCP principles is to provide an ethical treatment to the subjects who are involved in the clinical trials. Conference on GCP is important because it is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The GLP Principles describe requirements for and provide general guidance on the conduct of all nonclinical health and environmental safety studies, including invitro studies. Pre-clinical trials assess the toxicity of a drug and examine its potential effects on the human body. These trials are conducted in-vitro which is required to proceed with clinical trials. Good laboratory practices should be followed for these pre-clinical trials.
- Track 5-1Role of ICH in designing GCP principles
- Track 5-2Principles of GLP in vitro Studies
- Track 5-3OECD guidelines for the testing of chemicals
- Track 5-4Good Laboratory Practices (GLP) for Pre-Clinical Testing
- Track 5-5IEC-GCP regulations
- Track 5-6Pre-clinical trails
- Track 5-7Clinical trails
- Track 5-8SAS programming, usage in pharmaceutical industry
Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria that meets the requirements of the client or customer. A major aspect of quality control is the establishment of well-defined controls. These controls help standardize both production and reactions to quality issues. The role of Quality Impact Assessment & effectiveness checks is an essential operation of the pharmaceutical industry. To Perform Quality Control process of Project Management several quality control tools and software’s are required. Quality control also plays a major role in analytical method development so it would be great to attend the quality control summit.
- Track 6-1Quality control in project management
- Track 6-2Analytical quality control
- Track 6-3Drug product stability testing
- Track 6-4Quality control in textile industry
- Track 6-5Quality control in food industry
- Track 6-6Quality control in microbiology
- Track 6-7The role of quality impact assessment & effectiveness checks
- Track 6-8Methods of quality control
- Track 6-9Quality control tools
- Track 6-10Corrective and preventative action (CAPA)
Quality assurance is defined as a procedure or set of procedures intended to ensure that a product or service under development meets specified requirements. A quality assurance system is said to increase customer confidence and a company's credibility, to improve work processes and efficiency, and to enable a company to better compete with others. Quality assurance conferences aims at the need for Effective Internal and External Quality Assurance Auditing and it is required, by all active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical cGMP regulations published worldwide. Quality assurance testing is done by using software called Quality Metrics.
- Track 7-1Effective internal and external quality assurance auditing
- Track 7-2Quality risk management
- Track 7-3Quality inspection and auditing
- Track 7-4Quality by Design(QbD)
- Track 7-5Quality metrics & total quality management
- Track 7-6Quality assurance testing
Validation means establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. The Major Phases of validation include Pre validation, Process Validation and Validation maintenance Phase.
- Track 8-1 Cleaning validation and process validation of biopharmaceuticals
- Track 8-2Analytical method validation and computer system validation
- Track 8-3Change control
- Track 8-4Phases of validation
- Track 8-5HVAC system validation
Traditional role of Contract manufacturing, also known as outsource manufacturing, is to produce one or more components of a final product in which a company relies on the skills of specialist manufacturers. Six Sigma is a long-term, forward-thinking initiative designed to fundamentally change the way corporations do business. It is first and foremost "a business process that enables companies to increase profits dramatically by streamlining operations, improving quality, and eliminating defects or mistakes in everything a company does. Aseptic/sterile production and injectable manufacturing processes require a significant investment in terms of expertise, equipment, process, technology and quality control.
- Track 9-1Traditional role of contract manufacturing
- Track 9-2Quality over quantity in contract manufacturing
- Track 9-3Microbiological basics, sterilization processes & environmental monitoring
- Track 9-4Requirements for successful contract manufacturing partnerships
- Track 9-5Six sigma approaches and lean manufacturing
Cold chain storage is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is used to help extend and ensure the shelf life of pharmaceutical drugs. Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. Supply Chain integrity, enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products.
- Track 10-1Good distribution practices
- Track 10-2Manufacturing execution system (MES)
- Track 10-3New GDP guidelines
- Track 10-4Cold chain storage
- Track 10-5Supply chain integrity
Formulation development is to be done only after successful completion of pre-formulation studies. Optimization of existing formulations is required to create new products, Reduce costs, to capitalize on trends with greater profitability, novel formulations for improved delivery of existing dosage forms, to quickly recalculate formulations based on defined criteria, to create compliant products faster by using existing validated formulas. Product/Process optimization is the practice of making changes or adjustments to a process such as Conjoint Analysis, typically used in industrial process optimization.
- Track 11-1Pre-formulation development
- Track 11-2Formulation development
- Track 11-3Optimization of existing formulations
- Track 11-4Product/Process optimization
- Track 11-5Novel formulations for improved delivery of existing dosage forms
- Track 11-6Physico-chemical testing
- Track 11-7Process scale-up and technology transfer
- Track 11-8Batch manufacture
The Quality control in typical food processing has a significant role in assuming a high quality, safe and nutritious food supply for the public, for their good health and for the economic benefits derived from trade of safe and high quality food. Quality control conference also plays a major role in food industry. Hazard Analysis & Critical Control Points (HACCP) is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. Food, Drug, and Cosmetic Act is a set of laws giving authority to the US-FDA to oversee the safety of food, drugs, and cosmetics. Cleaning, disinfection and hygiene should be strictly maintained in food industry.
- Track 12-1Hazard analysis and critical control points (HACCP)
- Track 12-2Quality control in a typical food processing system
- Track 12-3Cleaning, disinfection and hygiene
- Track 12-4Validation practices in the food industry
- Track 12-5Current food industry good manufacturing practices
- Track 12-6Food, drug and cosmetic act (FDCA)
Microbiological Assay is defined as the determination or estimation of concentration or potency of an antibiotic by means of measuring and comparing the area of zone of inhibition or turbidity produced by test substance with that of standard over a suitable microbe under standard conditions. FDA 510k Testing regulation is found in 21 CFR 807 includes information required in a 510(k). The 510(k) is not a form. Cleaning, disinfection and hygiene should be strictly maintained in Microbiology and Biotechnology.
- Track 13-1FDA 510k testing
- Track 13-2Contamination control, cleaning, disinfection and hygiene
- Track 13-3Qc in microbiology lab
- Track 13-4Sterility assurance and sterility testing
- Track 13-5Microbial assays
- Track 13-6Validation of microbial recovery
The use of GMP software systems in regulated industries is vital throughout all aspects of the manufacturing process. Quality management software provides a flexible and configurable platform for tracking and managing quality and compliance events to ensure that manufacturing activities are continually measured, monitored and improved upon. In addition to managing all aspects of the audit process, GMP software solution manages the associated findings or observations, corrective and preventive actions (CAPAs), risk assessments, risk management and the analysis and approvals of changes. This software also manages deviations, process validation, complaint handling, manufacturing incidents, training records and more.
- Track 14-1GMP auditing compliance software
- Track 14-2Software quality control
- Track 14-3Regulatory compliance software
- Track 14-4cGMP software systems
- Track 14-5GxP (GMP, GCP & GLP) software systems
- Track 15-1Documentation
- Track 15-2Drug Development
- Track 15-3Regulatory submission and correspondence
- Track 15-4Accelerating drug approval timelines
- Track 15-5Clinical trials in emerging markets
- Track 16-1Excipient Specifications and Stability
- Track 16-2Excipient Consistency and Control
- Track 16-3Excipient Risk Assessment
- Track 16-4Supply Chain Issues
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