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8th International Conference on cGMP, GCP & Regulatory Affairs, will be organized around the theme “Meeting standards of drug regulations & achieving GxP compliance ”

GMP Summit 2018 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 2018

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 3-1Pharmaceutical cGMPs for the 21st Century
  • Track 3-2EU-GMP guidelines (European union-GMP guidelines)
  • Track 3-3WHO-GMP guidelines (World health organization-GMP guidelines)
  • Track 3-4GMP for active pharmaceutical products
  • Track 3-5 GMP for biopharmaceuticals
  • Track 3-6cGMP quality principles for biologics and biotechnological products
  • Track 3-7 Licensing in pharmaceutical production & GMP documentation
  • Track 3-8 Issuance and retrieval of GMP records
  • Track 3-9 Cancellation of GMP records
  • Track 3-10Good Documentation Practice (GDP)
  • Track 3-11Role of GxP in medical and food industries
  • Track 3-12 Good Engineering Practice (GEP)
  • Track 3-13Good Auditing Practice (GAP)
  • Track 3-14 Good Review Practice (GRP)
  • Track 3-15 Role of GxP and c GxP in biopharmaceutical Industry

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 8-1Cleaning 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 10-4New GDP guidelines
  • Track 10-5Cold chain storage
  • Track 10-6Supply 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

An administrative science driven administrative procedure is crucial as a component of today's biopharmaceutical item early advancement arranging. An all-around arranged administrative methodology will adjust the proposed clinical advancement arrangement with business targets, and pre-emptively distinguish challenges, and also, proposed elective/creative ways to deal with new item improvement which influence new measures for confirmation era supporting proceeding with improvement and worldwide business sector approval. An administrative methodology characterizes key issues/difficulties to proactively talk about with Regulatory powers furthermore characterizes key system points of reference that are frequently considered business impetuses driving speculator intrigue and financing. In particular, an auspicious, very much arranged and all around kept up administrative technique, with proactive and collective cooperation with administrative powers, is regularly a separating element for industry pioneers putting up monetarily fruitful and creative items for sale to the public in today's aggressive commercial center. Administrative procedure is a noteworthy segment of fruitful biopharmaceutical item improvement. Covance Global Regulatory Affairs gets ready and keeps up administrative science driven and item particular worldwide administrative systems for some item sorts, e.g., drugs, biologics, drug-gadget mixes, antibodies, quality treatments, cell-treatments, over a scope of restorative territories and full administrative technique support for item improvement activities.

 

  • 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

Excipients play an important role in formulating a dosage form. These are the ingredients which along with Active Pharmaceutical Ingredients make up the dosage forms. Excipients act as protective agents, bulking agents and can also be used to improve bioavailability of drugs in some instances, Excipients affect the physicochemical characters of the active pharmaceutical ingredient which may lead to formation of molecular complexes, increase in rate of chemical degradation etc.

  • Track 16-1Excipient Specifications and Stability
  • Track 16-2Excipient Consistency and Control
  • Track 16-3Excipient Risk Assessment
  • Track 16-4Supply Chain Issues

Non-compliance costs are costs which result from a failure to comply with regulation. These costs are not considered to be part of the regulatory burden for the purposes of the RBM. This includes penalties and associated activities that are required to be undertaken as a result of non-compliance with a regulation. Regulatory impacts that arise, up to the point that action is taken to respond to the suspicion of a specific instance of non-compliance, are included in the RBM framework. This includes risk based frameworks that may target certain populations without a specific instance of suspicion. “FCPIAA defines a CMP as any penalty, fine, or other sanction that is for a specific monetary amount as provided by Federal law; or has a maximum amount provided for by Federal law; and is assessed or enforced by an agency pursuant to Federal law; and is assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal Courts”. Failure to comply with the law can lead to enforcement action including one or more of the following: on-the-spot fines, prosecution, which carries a maximum fine of $12,110, disciplinary action, ranging from fines to cancellation of the license

  • Track 17-1Consumer Price Index (CPI)
  • Track 17-2Civil Money Penalties
  • Track 17-3Noncompliance
  • Track 17-4FCPIAA, Federal Civil Penalties Inflation Adjustment Act

The most important piece of UK legislation that would need to be repealed is the European Communities Act 1972 (ECA), which provides for the supremacy of EU law. Repealing the ECA will bring an end to the constitutional relationship that exists between EU and UK law. Moreover, the vast amounts of secondary legislation that have been passed with the objective and justification of implementing EU law would have to be considered by the Government. EU Regulations rely on the principle of direct applicability, which means that unlike EU Directives, they are directly implemented into UK law without the need for legislation from the UK Parliament. In this light, Regulations are more powerful legislative tools for the EU because of their immediate applicability. The status of existing Regulations will be addressed in the Great Repeal Bill, although as noted above, in many cases amendments will likely be needed to take into account the UK’s new relationship with the EU. The Court of Justice of the European Union (CJEU) situated in Luxembourg is the final arbiter on questions of the interpretation of EU law. In her first speech setting out the UK Government’s priorities for Brexit on 17 January 2017, the Prime Minister restated her position that the UK is not prepared to continue to be subject to the jurisdiction of the CJEU. 

  • Track 18-1Brexit effects on Pharmacovigilance and Protocols
  • Track 18-2Brexit effects on Clinical Trials
  • Track 18-3Exclusions and inclusions in regulatory affairs
  • Track 18-4Pharmacoeconomic aspects of Brexit

Due to the growing interest in marketing new products, it is pivotal to establish a superior level of medical writing and regulatory operations. Executives within these roles need to create and manage successful submissions, as well as streamline timelines, to accelerate approval.

Attending the Optimizing Regulatory Communications and Submissions conference will aid delegates in expediting the approval of drugs while meeting requirements for different regulatory agencies worldwide. In addition, attendees will overcome key operational challenges impacting the approval process to enhance the quality of submissions.

  • Track 19-1Global guidelines for the development of biologics
  • Track 19-2Trends in designing chemistry, manufacturing and controls (CMC) components of regulatory submissions
  • Track 19-3Current Trends in Planning, Preparation and Delivering Regulatory Submissions
  • Track 19-4Current Trends in Planning, Preparation and Delivering Regulatory Submissions
  • Track 19-5FDA CDER and CBER review
  • Track 19-6Speed Biologics development
  • Track 19-7Global trend for Biologics
  • Track 19-8Regulating regenerative medicine
  • Track 19-9Cosmetics
  • Track 19-10CTD, eCTD

As therapeutic gadget quality certification and administrative undertakings experts, it can test to remain focused of changes occurrence in our industry. Administrative controls for restorative gadgets are rare in the creating scene, despite the fact that usage of national medicinal gadget directions will frequently address the very issues brought up in nations as significant attentiveness toward patient wellbeing. Case of these issues incorporate the unlawful re-preparing and re-bundling of utilized syringes for re-deal; the accessibility available of hardware that fizzles least quality and security benchmarks; or just no hint of what gadgets are being sold in the nation, nor by whom. Such a posting is crucial to empower governments to issue cautions or reviews for perilous or inadequate things.

 

  • Track 20-1FDA regulation
  • Track 20-2Pharmacoeconomics & outcomes research
  • Track 20-3Compliance strategies
  • Track 20-4Unique Device Identification (UDI) in the USA
  • Track 20-5Identification of Medicinal Products (IDMP) in Europe
  • Track 20-6The New EU Medical Device Regulation