Conférences  >  Médecine & Soins de Santé  >  Législation en médecine et pharmacologie  >  États-Unis

FDAMap

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

Sop, Quality Management System, FDA Regulation, FDA Compliance

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

FDAMap

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

Sop, Quality Management System, FDA Regulation, FDA Compliance

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

FDAMap

The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others.

Technical Writing, Regulatory Writing, FDA Regulations, FDA compliance

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

FDAMap

The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others.

Technical Writing, Regulatory Writing, FDA Regulations, FDA compliance

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

FDAMap

Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. Most of the refuse-to-accept deficiencies are due to the inexperience of the 510k writers, who ignore the FDA rules. Writing and assembling a complete and well structured 510(k) submission will certainly improve the likelihood of FDA clearance on the first round.

This hands-on workshop is done by one of the industry’s top regulatory expert. The trainer has performed numerous reviews of 510(k) submissions over the last 15 years, and has analyzed the reasons that most often lead to delays in getting submissions ultimately cleared by FDA. This hands-on workshop will walk the attendees through the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.

510 k Submissions, FDA Regulations, FDA Compliance

CHI

The Bio-IT World Conference & Expo is the premier global event showcasing the technologies and analytic approaches that solve problems, accelerate science, and drive the future of precision medicine. From April 2-4, 2025, our 24th annual gathering will bring together global experts in the fields of biomedical research, drug discovery & development, and healthcare to explore cutting-edge innovations and best practice applications. Conversations here will connect you with the people, ideas, and opportunities you need to build your business and advance your research. The program offers inspiring plenary keynotes, over 200 educational and technical presentations, three days of networking opportunities, and an exhibit hall featuring leading technology and scientific solutions providers.

Tél.: [781.972.5400];     Email.: chi@healthtech.com

FDAMap

​Clinical trials are highly regulated multi-dimensional projects that require constant interactions between the regulators and the sponsors, investigators, other personnel, and even patients involved in the conduct of a given trial. There are many diverse tasks involved in the conduct of a clinical trial starting from the development of a clinical trial protocol, finding and starting clinical trial sites, filing of an IND or IDE application, approvals from IRBs, numerous documents need to be collected to demonstrate compliance with regulations; managing supplies, collecting data, writing reports, and many other things. Clinical project managers need to understand, implement, and trouble-shoot practically all aspects of the clinical trial under them. Clinical project managers have to build teams and have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. This one-of-a-kind program will train you in regulatory affairs, clinical operations, monitoring, patient recruitment and retention, planning, medical writing, safety monitoring and practically all major aspects of running a clinical trial.

Clinical Project Management, FDA Regulations, FDA FDA Compliance

ComplianceOnline

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in each country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping. These requirements include the required education, training and experience for employees whose activities affect the quality of drug products. Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training.

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

Good Manufacturing Practices, GMP, pharmaceutical production, cGMP, GMP training, GMP compliance, US FDA regulations, drug manufacturing laws, GMP laws, pharmaceutical industry, GMP education, pharmaceutical compliance, GMP training seminar, noncompliance consequences, GMP enforcement

CHI

Medtech MVP is an annual gathering of the leading innovators, investors and executives from around the nation discussing the timeliest issues and opportunities. This conference features candid discussions (panels or 1-on-1 conversations) that explore relevant topics for medtech innovators and business leaders as well as ample networking in a tight community. The many years of successful Medtech MVP programming have relied on insightful and beneficial perspectives and recommendations from our various keynotes and panels.

Tél.: [781.972.5400];     Email.: chi@healthtech.com

Magnus Group

Prepare to immerse yourself in the 5th Edition of the International Vaccines Congress (IVC 2025), taking place from October 23-25, 2025, in the vibrant city of Orlando, Florida, USA! This highly anticipated International Vaccines Congress 2025 will offer a unique hybrid format, seamlessly blending onsite and online experiences to maximize global reach and participation. Dive deep into the latest advancements and transformative trends in vaccine science under the theme: From Discovery to Distribution: The Path of Vaccines.

Tél.: [17029882320];     Email.: vaccines@magnusconference.com