Conférences  >  Médecine & Soins de Santé  >  Pharmacologie et développement des médicaments  >  États-Unis

ComplianceOnline

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations. In this course you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.

Regulatory requirements for SOPs, Consequences of noncompliance, Parameters of an effective SOP, Distinguishing good SOPs from poor SOPs, Simulation of interview with stakeholders, Relationship between SOPs and training curricula, Tools in Learning Management Systems,

Médecine translationnelle, essais cliniques,    Législation en médecine et pharmacologie

ComplianceOnline

Seminar participants will learn the following: Gain an understanding of the fundamental principles and skills necessary to conduct Aseptic Processing of Sterile Drug Products with minimum risk, Analyze issues impacting Aseptic Processing to include the environment, personnel, gowning and sanitization, Acquire the skills necessary to control the process environment, Minimize media fill failures to permit production throughput, Determine how to develop media fill simulations to include the "worst case" scenarios, Learn best practice techniques for determining media fill sizes, Understand the "critical factors" required to maintain compliance, Decrease inspectional observations, Avoid Warning Letters and Consent Decrees

aseptic processing, environmental monitoring, gmp, sterile drug products, fda guidance for sterile products, sterile filtration during accepting processing, aseptic sterile manufacturing, aseptic process validation, aseptic fda guidance

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.

FDA, Clinical Project Management, FDA Regulation, FDA Compliance

Législation en médecine et pharmacologie,    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.

FDA, 510(k) Submissions, FDA Regulation, FDA Compliance

ComplianceOnline

In this two half-day workshop conference you will learn how GMP applies directly to virtual company operations, how to best structure a quality management system in a virtual company, and a method to decide which procedures are necessary at what points in time. You will also learn best practices for quality agreements and vendor management. In addition, you will learn the current guidance from FDA for application of GMP to the manufacture of Phase 1, 2 and 3 clinical trial materials. Though FDA requirements are the primary emphasis, some discussion of EMA (European) requirements and other venues will also be included.

phase appropriate gmp, fda gmp workshop, FDA GMP Expectations, Phase I, First-in-Man Clinical Trials, CMC Requirements, IND Study, Raw Material Management, 505(b)(2) Products process Validation, ISO 9001:2015 QMS, Combination Products

Biotechnologie,    Législation en médecine et pharmacologie

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.

FDA, SOPs, FDA Regulation, FDA Compliance

Législation en médecine et pharmacologie,    Médecine translationnelle, essais cliniques

FDAMap

In the field of regulatory affairs, professionals often encounter the task of writing complex documents for diverse audiences. These documents encompass a wide range, including reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and various communication documents. 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.

FDA, ​Technical Writing, Regulatory Writing, FDA Regulation, FDA Compliance

Législation en médecine et pharmacologie,    Médecine translationnelle, essais cliniques

American Society for Experimental Neurotherapeutics (ASENT)

ASENT's 2026 Annual Meeting is the premier neuroscience and neurotherapeutics conference where leaders from providers and prescribers, employers, investors, fast-growing startups, big pharma, policymakers, funders & innovation centers gather to improve the process of bringing neurotherapeutics to market.

Tél.: [8332731556];     Email.: jessica@asent.org

Neurology, Neurotherapeutics, Neuroscience, Biotech, Bioengineering, FDA, NIH, Drug Development, Pipeline Presentations

Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance.

verification and validation training seminar, V&V product equipment software QMS training, FDA verification and validation best practices course, master validation plan development webinar, risk-based V&V planning training, product verification and validation compliance seminar, equipment and process validation course, software validation webinar for regulated industries, QMS validation and 21 CFR Part 11 training, risk-based approach to V&V workshop, V&V project management seminar, ISO 14971 and ICH Q9 V&V risk management course, develop V&V files and protocols training, V&V planning and documentation workshop, DQ IQ OQ PQ validation techniques seminar, validation protocols for production equipment course, software V&V 11-element FDA requirements session, QMS electronic records and e-signatures validation webinar, V&V change control implementation seminar, validation case studies and templates training, regulated industry validation best practices seminar, pharmaceutical and medical device V&V course, diagnostics and biologics V&V training, compliance with FDA and EU validation standards, validation audit readiness training, V&V roles and responsibilities for QA and regulatory affairs, process and software validation fundamentals, monitoring and test equipment validation training, V&V milestone and task planning course, V&V in resource constrained environments training, validation test case and script construction workshop, GAMP-based validation planning seminar, lean validation documentation course, cloud and ERP system V&V training, senior management V&V strategic workshop, validation risk assessment and hazard analysis training, validation checklist and templates seminar, quality system validation essentials training, regulatory compliance for verification and validation, product quality verification workshop, validation sample size justification training.

Législation en médecine et pharmacologie,    Pharmacogénétique, Médecine personnalisée

BOC Sciences

March 23rd, 2026 10:00 EDT

This webinar, featuring Prof. Nikolai Petrovsky, explores how recent research and tools like artificial intelligence are unlocking the broad pharmaceutical utility of polysaccharides, using inulin as a key case study.

Event Administrator;     Email.: account@bocsci.com

Chemistry and properties of polysaccharides; Research tools for polysaccharides; Solving polysaccharide structures using AI; Pharmaceutical utility of polysaccharides;

ComplianceOnline

One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes did not adversely impact products, processes, equipment, facilities, etc. A single inadequate change may lead to significant negative events, including release of sub-standard product or product recall. A pattern of inadequate changes may require costly and time-consuming system remediation efforts.

FDA change control training seminar, change control best practices workshop, FDA change control expectations course, pharmaceutical change control compliance training, change control regulatory requirements USA, FDA-focused change control program training, virtual seminar for change control professionals, change control risk assessment training, GMP change control training online, FDA documentation and change control compliance, best practices for FDA change control in pharma manufacturing, how to comply with FDA change control requirements 2026, step-by-step change control process training seminar, change control risk assessment and execution webinar, pharmaceutical quality systems change control workshop, change proposal and justification training for regulated industry, document control vs equipment change control seminar, change control plan documentation best practices course, avoiding common FDA 483 citations change control strategies, critical thinking for successful change control implementation, FDA warning letter examples change control, risk-based change management in biotech, change execution plan templates, change control inspection readiness training, integrated change control process model, change control for validation engineers, regulatory filings for major manufacturing changes, change control in medical device environments, change control accreditation certificate course, FDA compliance checklist for change control, pharmaceutical quality compliance training, FDA 483 inspection change control deficiencies, change impact assessment best practices, quality management system change control, supplier and material change control strategies, like-for-like change controls, emergency change control guidelines, change control documentation package, subject matter expert change review, process validation and change control integration, FDA inspection readiness change control, change control warning letter prevention, how to write change proposals for FDA compliance, change justification risk assessment methods, executing and implementing regulated manufacturing changes, QMS and change control integration, training for validation staff change control, change control for QA QC teams, engineering and production management change control training, regulatory compliance seminar for pharmaceutical professionals, biotech change control training program, medical device change management compliance course

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.

good manufacturing practices seminar, GMP compliance training online, current good manufacturing practices course, GMP regulatory requirements workshop, FDA and international GMP best practices seminar, pharmaceutical manufacturing GMP training, GMP quality systems and compliance course, risk management in GMP environment training, GMP facility and HVAC control seminar, raw materials and supplier management GMP training, deviation investigation and CAPA under GMP, annual product review and GMP compliance seminar, contamination control and cleanroom GMP workshop, GMP documentation and record keeping training, personnel competency and GMP requirements course, process control and production GMP seminar, equipment and utilities GMP compliance training, quality assurance GMP fundamentals webinar, GMP inspection readiness training, cGMP pharmaceutical industry workshop, global GMP standards training, GMP training for QA/QC professionals, GMP training for operations managers, GMP risk assessment and mitigation seminar, regulatory audit readiness GMP course, drug and biologics GMP compliance webinar, GMP certification preparation training, quality management and SOPs under GMP requirements, GMP case studies and examples seminar, contamination prevention and control best practices, GMP for medical device manufacturing, compliant manufacturing processes workshop, GMP training for supply chain professionals, GMP training for regulatory affairs teams, advanced cGMP principles course.

Législation en médecine et pharmacologie,    Pharmacogénétique, Médecine personnalisée

The objective of this on-line, interactive two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn their current and updated status and to confirm that those Chapters being utilized are used correctly.

USP microbiology chapters seminar, essentials of USP microbiology training, USP general and information microbiology course, pharmaceutical microbiology compliance webinar, USP microbiological examination of nonsterile products training, USP microbiology sterility test seminar, bacterial endotoxins test training, antimicrobial effectiveness testing course, USP microbial control and monitoring HVAC training, microbiological raw material testing seminar, API microbiology testing and control workshop, USP microbial characterization and identification training, application of water activity in microbiology, validation of microbial recovery training, sterile and non-sterile microbiology chapter interpretation, harmonization USP EP JP microbiology requirements, objectionable and specified microorganisms seminar, pharmaceutical HVAC microbial environment course, FDA 483 microbiology inspection readiness, microbiological best lab practices webinar, bioburden control seminar, microbial contamination control in pharmaceutical manufacturing, microbiology for QA QC regulatory professionals, microbiological environmental monitoring training, USP microbiology general info test methods, endotoxin and sterility assurance course, pharmaceutical microbiology documentation and SOP seminar, non-sterile product microbial testing course, controlled vs classified environment microbiology training, raw material bioburden sampling criteria workshop, microbiology course for regulatory affairs, aseptic processing microbiological control training, microbial risk assessment in pharmaceutical environments, USP microbiology harmonization training, HVAC microbial contamination control seminar, microbial compliance strategies for APIs and raw materials.

Biotechnologie,    Législation en médecine et pharmacologie

Keystone Symposia

There have been tremendous advances in developing novel nucleic acid-based strategies for treating human diseases. Recent clinical successes have validated nucleic acid-based platforms, documenting that they can provide life-changing medicines to patients who need them. However, efficient delivery of these nucleic acid payloads to the cell type of interest and the appropriate subcellular compartment still limits their full potential despite significant progress over the past decade. This meeting is designed to bring together scientists from multiple disciplines, all working on delivery of nucleic acid cargos to cells. The meeting will cover the latest designs for viral vectors, lipid nanoparticle systems, virus-like particles, and ligand conjugates to enhance delivery of nucleic acid payloads. This meeting is unique in bringing scientists working on these different strategies for drug delivery into a single venue. Although these strategies have the common goal of enhancing intracellular delivery of nucleic acid cargo they tend to be siloed. A key goal of the meeting is to bring scientists together who have different expertise and perspectives to learn from each other, enabling more rapid and effective solutions for these delivery challenges. This will be a joint conference with the genome engineering meeting, which creates a lot of synergies. The genome engineering will discuss various nucleic acid cargo, while this meeting will focus on delivery technologies for the nucleic acid cargo. This meeting will be held jointly with Precision Genome Engineering: From Laboratory to Clinic.

Genetics, Genomics, RNA, Nucleic Acid Therapeutics, Drug Delivery, Gene Therapy, Viral Vectors, Nanoparticles, Translational Research

Biologie moléculaire,    Génomique et bio-informatique