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7th International conference on Pharmaceutical Auditing , will be organized around the theme “Considerations of Compliance And Regulatory Audits In Pharmaceutical Industry”
Pharma Audit 2018 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Pharma Audit 2018
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Quality assurance (QA) and independent audit is critical in the pharmaceutical industry to assure reliability of the products, adherence to approved specifications, and conformation of current good manufacturing practices (cGMP) to regulation. Manufacturers must establish a quality control unit that is responsible for quality-related activities required by the regulations. Quality is determined by whether the firm complies with GMP requirements and makes scientifically justified decisions. Pharmaceutical companies are now taking a proactive stance with the new GMP Systems approach, more effective internal auditing and increased regulatory awareness throughout the company.
- Track 1-1Pharmaceutical Manufacturing Environment
- Track 1-2Quality Control
- Track 1-3Analytical Instruments
- Track 1-4Quality Management System (QMS)
- Track 1-5Quality Management System (QMS)
- Track 1-6Laboratory Control System
Administrative issues is a relatively new calling which created from the yearning of governments to ensure general wellbeing by controlling the security and viability of items in ranges including pharmaceuticals, veterinary drugs, therapeutic gadgets, pesticides, agrochemicals, beautifying agents and correlative meds. Regulatory Affairs is included in the improvement of new restorative items from at an early stage, by coordinating administrative standards and by get ready and presenting the pertinent administrative dossiers to wellbeing powers.
Regulatory Affair effectively required in each phase of improvement of another prescription and in the post-advertising exercises with approved therapeutic items. The Regulatory Affairs office is a vital part of the hierarchical structure of pharmaceutical industry. Inside it liaises at the interphase of medication advancement, assembling, promoting and clinical research. Remotely it is the key interface between the organization and the Regulatory powers.
- Track 2-1Career development in regulatory affairs
- Track 2-2Regulatory strategies and developments
- Track 2-3Regulatory communications and submissions
- Track 2-4Regulatory challenges for medical devices
- Track 2-5Regulatory requirements for pharmaceuticals
- Track 2-6Global regulatory intelligence
Testing laboratories provide vital services to their customers who expect accurate results produced at appropriate time and at reasonable cost. Adoption of the quality management system (QMS) by a laboratory would facilitate achieving these goals. The International Organization for Standardization (ISO) has developed an international standard, known as ISO 17025: 2005 ‘General requirements for the competence of testing and calibration laboratories’, for the accreditation of testing laboratories to a wide range of testing environments. Compliance with this quality standard requires that the laboratory shall establish and maintain a systematic way to ensure and improve its performance. Compliance with the ISO 17025 provides a unique focus for assuring implementation of the QMS and technical competence of a laboratory.
- Track 3-1Elements of the quality management system
- Track 3-2Organization and responsibilities
- Track 3-3Internal and external audits
- Track 3-4Corrective and preventive action
- Track 3-5Management review and continual improvement
International Organization for Standardization (ISO) 9000 requirements do not have the same status of “the law” in the U.S. as do requirements listed in the Code of Federal Regulations (CFR). Because 21 CFR 210 and 211 have legal status, the U.S. Justice Department has extensive powers to ensure compliance. For example, product in the marketplace can be seized, fines can be levied, and personal liability can be assigned. So, management must understand that auditing must be taken seriously, and the requirements listed are just that – requirements. While audits are the common place in the pharmaceutical industry, the preparedness for those events varies. The companies that develop a risk-based approach to audits are able to remain competitive while meeting quality and government compliance standards on a regular basis. Conversely, the companies that have not implemented strong processes are putting themselves at risk for non-compliance. According to the Federal Food, Drug and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Under some conditions the inspections may be even more frequent, As regulations become more stringent, regulatory authorities are likely to step up audits which is even more reason for companies to be prepared.
- Track 4-1The Audit as a Quality Control Mechanism
- Track 4-2Adequate supervisory control
- Track 4-3Quality control plans
- Track 4-4Proper administration of a benefit plan
The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. The setting of global standards is requested in Article 2 of the WHO Constitution, which cites as one of the Organization’s functions that it should “develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products.” The supply of essential medicines of good quality was identified as one of the prerequisites for the delivery of health care at the International Conference on Primary Health Care in Alma-Ata in 1978. Similarly, the Conference of Experts on the Rational Use of Drugs, held in Nairobi in 1985, and WHO’s Revised Drug Strategy, adopted by the World Health Assembly in May 1986, identified the effective functioning of national drug regulation and control systems as the only means to assure safety and quality of medicines.
- Track 5-1Good manufacturing practices for pharmaceutical products (GMP)
- Track 5-2Sanitation and hygiene
- Track 5-3Good practices in production
- Track 5-4Quality management in the drug industry
Among the essential elements of a well-established Quality Management System (QMS), deviation handling plays a key role in assuring quality in products and by contributing to continuous improvement. Manufacturers are expected to “establish processes and define appropriate controls for measurement and analysis to identify nonconformities and potential nonconformities, defining when and how corrections, corrective actions, or preventive actions should be undertaken. These actions should be commensurate with the significance or risk of the nonconformity or potential nonconformity. GMPs have evolved as a consequence and of the inherent risks to the product during manufacturing operations in order to prevent significant deviations. More recently, Quality Risk Management (QRM) has been proposed as a strategy to manage risk in a systematic and documented manner, and has become a requirement of modern GMPs as recommended by international standards like WHO or ICH.
- Track 6-1Deviation handling
- Track 6-2Corrective and Preventive Actions (CAPA)
- Track 6-3Risk Assessment
- Track 6-4Risk Control
- Track 6-5Quality risk management tools
FDA cannot meet the goals of the Initiative alone. The success of the Initiative has been predicated on active participation and input from experts in industry, academia, government, and consumer groups. Emphasize the importance of the Initiative and look forward to many more improvements in regulatory processes for ensuring product quality. The following organizational components of FDA have been actively involved in working toward this modernization over the last four years: ORA, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation (CDER) and the Center for Veterinary Medicine (CVM), along with various offices within the Office of the Commissioner. All of these organizations continue to promote the goals and objectives of the Initiative and are dedicated to continuing to improve the regulation of pharmaceuticals in the 21st Century.
- Track 7-1Internal Quality Management Systems
- Track 7-2External Quality Management Systems
- Track 7-3Process Analytical Technologies
- Track 7-4Scientific collaboration activities
Laboratory activities are one of the main functions in Pharmaceutical Industry. In the current time, analytical chemists are involved in several audits or inspections either as an auditor/inspector or as someone being audited / inspected. Understanding the auditing process has proved to be beneficial to handle your internal and external audits. Effective auditors can help to achieve and maintain quality management system registration as well as identify opportunities to improve overall performance.
- Track 8-1Understand the main objectives for conducting laboratory audit and inspections
- Track 8-2Discuss how to prepare for conducting an audit
- Track 8-3Learn how to assembling an audit team
- Track 8-4Identify the areas of deficiencies
- Track 8-5Review the do’s and don’ts during the audit
- Track 8-6Prepare the audit report
- Track 8-7Implementation of a company wide data integrity program
Non-prescription medicines, commonly known as over the counter or OTC medicines, are used for treatment. Sales of over the counter medicines in pharmacy and grocery outlets reached £1268 5 million in 1994 about a third of the NHS drugs bill of C3 6 billion. In the late 1980s the government fuelled the over the counter market by making it easier to reclassify certain medicines from prescription only status to allow over the counter sale in pharmacies. Although all non-prescription medicines are required to hold a product licence, few have been evaluated in formal clinical trials in the setting in which they will be used. As a result many non-prescription products sold by pharmacists have been criticised for their lack of effectiveness. There are three legal categories of medicines prescription only medicine (POM), pharmacy medicine (P), and general sales list medicine (GSL); the last can be sold from outlets including supermarkets and drugstores. The principle of a class of medicines whose sale requires the supervision of a pharmacist is not unique to the United Kingdom.
- Track 9-1Analysis and information on possible risk of incorrect or delayed diagnosis arising from non-prescription use
- Track 9-2Audit tools based on 21 CFR 210 & 211, ICH Q10
- Track 9-3Standardized grading scheme
- Track 9-4Building and facility maintenance
- Track 9-5Equipment validation
- Track 9-6Laboratory operations
- Track 9-7Product traceability
- Track 9-8Audits, including capacity, quality assurance and post-market quality system verification
One of the critical tasks for a Good Laboratory Practices (GLP) nonclinical laboratory study or Clinical Trial team is choosing a bioanalytical laboratory vendor that will meet their study needs. A well-managed bioanalytical study with proper Sponsor oversight will go a long way to ensure the generation of accurate data and quality data. Many companies have a Research & Development Quality Unit that includes people with auditing skills in Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs). Many R&D auditors have a background in what is required to audit a bioanalytical laboratory for either Clinical trials, GLP, GLP-Like or best laboratory practices. Bioanalytical Laboratory Vendor Qualification Audits.
- Track 10-1Sample Handling, Sample Chain of Custody
- Track 10-2Method Validation
- Track 10-3Computer System Management
- Track 10-4GDP and GLP compliance
- Track 10-5Operating procedures and protocol compliance
- Track 10-6Clinical Affairs & Regulatory Strategies
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 11-1Hazard analysis and critical control points (HACCP)
- Track 11-2Quality control in a typical food processing system
- Track 11-3Cleaning, disinfection and hygiene
- Track 11-4Validation practices in the food industry
- Track 11-5Current food industry good manufacturing practices
- Track 11-6Food, drug and cosmetic act (FDCA)
Clinical quality assurance audits, performed to ensure that scientific and ethical standards are met in the conduct of clinical trials, are conducted using proprietary computerized audit tools, customized to each project, so that GCP audit findings can be efficiently and consistently collected, analysed and reported. This focused systems-oriented approach to quality assurance is designed to assess and validate study conduct and documentation to ensure regulatory compliance and conformance to protocol, SOP and contractual requirements. Methodology should evaluate the activities and documentation underlying study data integrity and Good Clinical Practice (GCP) ethical and regulatory requirements.
- Track 12-1Clinical investigator site audits
- Track 12-2CRO and SMO audits
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.
- Track 13-1Good Clinical Practice (GCP)
- Track 13-2Contract Research Organizations (CROs)
- Track 13-3Standard operating procedures (SOPs)
- Track 13-4Investigational medicinal products (IMPs)
- Track 13-5Quality management