Conférences - Législation en médecine et pharmacologie - États-Unis

Compliance4All

Audits for cause focus on specific issues and require additional planning to uncover the root cause of the quality issue. This webinar will address key points to assess during the preparation and performance of GMP/GLP laboratory audits for laboratories conducting assays supporting biologics.

Compliance4all;     Tél.: [8004479407];     Email.: support@compliance4All.com

Compliance4All

The outbreak of coronavirus disease (COVID-19), first in the People's Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries. Congress is particularly concerned about these dependencies and has passed legislation to better understand and address them. An area of particular concern to Congress in the current environment is U.S. shortages of medical supplies - including personal protective equipment (PPE) and pharmaceuticals -as the United States steps up efforts to contain COVID-19 with limited domestic stockpiles and insufficient U.S. industrial capacity. PPE, antibiotics, and active pharmaceutical ingredients have led to shortages of critical medical supplies in the United States.

Compliance4all;     Tél.: [8004479407];     Email.: compliance4all14@gmail.com

Compliance4All

This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.

Compliance4all;     Tél.: [8004479407];     Email.: compliance4all14@gmail.com

Compliance4All

Regulatory agencies expect pharmaceutical companies and biopharmaceutical companies to use validated methods for late phase work. The methods are used to test large molecule drug substance or drug product for identity, purity, and potency. Poorly developed and inadequately validated methods often have high failure rates when in production. Data submitted from poorly developed/validated methods is subject to additional scrutiny due to the excessively high failure rate that lowers confidence in the data that is produced.

Compliance4all;     Tél.: [8004479407];     Email.: compliance4all14@gmail.com

Compliance4All

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes development of a company philosophy and approach, and incorporating it into an overall computer system validation program and plans for individual systems that are regulated by FDA.

Compliance4all;     Tél.: [8004479407];     Email.: compliance4all14@gmail.com

Complianceonline

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. This new upcoming regulation is also stronger connected to the EN ISO 13485:2016. The understanding of this changes and how to implement last minute changes until May 2021 is essential to keep your certificates. The first key for the understanding and the implementation of the changes is the knowledge about the interfaces between the EN ISO 13485:2016 and the EU MDR 2017/745. The second key is to understand, which parts of the EU MDR 2017/745 are not covered by the EN ISO 13485:2016. These not covered paragraphs and requirements must be additional implemented into the quality management system until May 2020. The time is short and immediately action is required.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

EU MDR 745/2017, EN ISO 13485:2016, iso 13485 2016 standard, iso 13485 standards iso 13485 clauses, eu medical device regulation

Complianceonline

Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance. Recent EU and FDA reports demonstrate that qualification, validation and electronic records are priority areas for inspection. The large number of FDA warning letters and the frequency of EU enforcement action in these areas demonstrate that companies sometimes struggle to understand or implement the regulations. This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national and international regulatory bodies. The course not only ensures a full understanding of the regulations and guidelines for equipment and records but helps attendees to develop a risk-based approach to compliance. Interactive exercises will be dispersed into and between the presentations.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Computer System Validation seminar, USP <1058>, GAMP 5, equipment calibration, system validation, qualification and validation strategy, archive raw data from hybrid systems, Analytical Instrument Qualification, USP General Chapter <1058>, instrument qualification lifecycle, 21 CFR Part 211, Part 11, PIC/S, EU Annex 11, GMP Computer Systems, Laboratory Computerized Systems, Use of Excel in QC Laboratory, revalidation of chromatography, data security and integrity issues.

Complianceonline

The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pharmaceutical regulatory authorities have. Enforcement penalties can be severe from a business standpoint, and in extreme cases can even impact individuals who are held responsible for the occurrence of data integrity problems. In recent months the topic of data integrity has been in the forefront of concern among worldwide pharmaceutical regulatory agencies. The FDA, EMA, TGA and others have published guidelines setting forth their requirements and expectations for the maintenance of data integrity, as has at least one leading industry organization (PDA). The use of computer systems in virtually every aspect of data acquisition, storage, and analysis can help preserve data integrity and reduce or eliminate many errors, but the same technology can also create unique problems that must be prevented and managed. In this two day workshop conference you will learn the meaning of "data integrity"; be exposed to some of the history that influences current regulatory requirements and expectations; see a comparison of the current guidance from leading regulatory agencies including the FDA, EMA, TGA and key industry associations such as the Parenteral Drug Association; see a recap of the enforcement options available to the FDA, including imposition of the Application Integrity Policy (also known as the "Fraud Policy"); discuss and learn from selected current real-life case histories; and hear advice for how to prevent, detect and react to data integrity problems so as to minimize business and regulatory risk.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

pharma data integrity, GMP, GCP, GLP, FDA, EMA, TGA regulations, data acquisition, ALCOA, Generic Drug Scandal, GXP operations, audit trails, computer system controls, PIC/S, pharmaceutical inspection convention, pharmaceutical inspection co-operation scheme, application integrity policy, MHRA, data integrity training

Complianceonline

This course is designed to cater for employees of pharmaceutical companies who would like an understanding of the drug development and regulatory approval process. The course starts by considering the global pharmaceutical market, important therapeutic areas and the roles of different pharmaceutical professionals in the development process, as well as a definition of drugs and medical devices. The drug development process, from discovery to post-marketing surveillance, is then explained. Topics include the identification of drug targets, synthesis of chemical drugs and the development of biologics, pharmacokinetics and toxicity screening, pre-clinical development, clinical studies, regulatory submissions, managing post-approval change, pharmacovigilance and an overview of regulations governing drug manufacture and distribution.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Drug development process, identification of drug targets, synthesis of chemical drugs, the development of biologics, pharmacokinetics, toxicity screening, pre-clinical development, clinical studies, regulatory submissions, managing post-approval change, pharmacovigilance, governing drug manufacture and distribution fda regulations, global pharmaceutical market size

Complianceonline

This two day highly interactive course will cover all aspects of radiation sterilization validation, materials selection and processing implementation. This workshop has been designed to help attendees learn the ins and outs of all the radiation modalities, materials selection, and validation of the sterilization process per ISO 11137. Additionally, 483 case studies will explore how to avoid the operational and legal issues that arise from nonconformance with regulators (FDA) and auditors.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Radiation sterilization for medical devices, sterilization validation, gamma radiation sterilization, E-beam sterilization, X-ray sterilization, irradiator designs, ISO 11137 requirements

Cambridge Healthtech Institute (CHI)

This conference is designed to facilitate knowledge and opinion exchange between pharmaceutical and diagnostics executives, translational scientists, clinicians, business experts, regulators, international companion diagnostics leaders, and other parties involved in drug-diagnostics co-development and precision medicine. Case studies of successful collaboration between pharmaceutical and diagnostics companies will be presented. This conference is part of the Next Generation Dx Summit.

Tél.: [781-972-5400];     Email.: reg@healthtech.com

drug, diagnostics, drug-diagnostics, medicare, drug reimbursement, diagnostic reimbursement, technology, technologies, lab tests, pharmaceuticals, biomarkers, immuno-oncology, precision medicine

Biotechnologie,    Génie biomédical

Cambridge Healthtech Institute (CHI)

At this conference, leaders working in the clinical lab, research, biotech, and pharma will come together to showcase the latest in diagnostic technology and find solutions for the biggest challenges facing the clinical lab, including managing workflow, incorporating NGS and molecular testing, gaining reimbursement and regulatory approval, and more. This conference is part of the Next Generation Dx Summit.

Tél.: [781-972-500];     Email.: reg@healthtech.com

diagnostics, advanced diagnostics, infectious diseases, infectious disease testing, molecular diagnostic test, MDx test, COVID-19, CRISPR, pandemics, POCT

Biotechnologie,    Biologie