Conférences - Législation en médecine et pharmacologie - États-Unis

Complianceonline

Complianceonline

Complianceonline

Complianceonline

Complianceonline

Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. This 2-day virtual seminar is designed to offer a broad overview of developing and validating a range of assay methodologies for biologics with specific key analysis of cell culture, assay variability, and DOE. Specifically, this seminar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. In addition to potency methods this seminar addresses immunogenicity methods for preclinical and clinical studies. The format of the seminar offers an examination of current best practices as well as time to dissect examples of documentation with emphasis on beneficial systems to consider. Scientists who attend this 2-day virtual seminar will gain knowledge that will be beneficial in helping to achieve well-controlled validated methods.

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

Attend this biologics seminar to learn essential concepts related to cell-based potency methods, ELISA, immunogenicity methods, analytical CMC methods, cell culture procedures, immunogenicity methods, and biomarker validation.

Complianceonline

Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP regulations affecting pharmaceutical quality control, this one-day course is designed to provide the non-specialist with the necessary knowledge to understand the quality significance and risk associated with different analytical operations.

Lab safety audit checklist, laboratory audit checklist, chemical laboratory audit checklist, pharmaceutical quality assurance, pharmaceutical guidelines for quality assurance, quality control of drugs, gmp guidelines for pharmaceuticals, laboratory inspection

Complianceonline

In this two day workshop conference you will learn the different global agencies expectations of equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors.

Equipment Qualification, DQ, IQ, OQ, PQ, Validation Processes, Change Control, Validation Master Plan (VMP), SOPs, QMS, Risk Analysis, FDA Warning Letters, case Study, FDA Compliance Seminar

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

brazil medical products regulation conference, Latin America regulations, Latin America life sciences regulations, Latam life sciences regulatory requirements, Latin America pharmaceutical regulations, Latin America medical device regulations, Latin America biologics regulations, Argentina life sciences regulations, Argentina medical device regulations, Argentina biologics regulations, Brazil life sciences regulations, Brazil medical device regulations, Brazil biologics regulations, Mexico life sciences regulations, Mexico medical device regulations, Mexico biologics regulations, Latin America clinical requirements, Latin America pre-clinical requirements

Complianceonline

Complianceonline

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.

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

USP Microbiology, USP microbiology chapters, USP general, USP General Chapter Changes, USP Chapters, USP document, HVAC, USP, EP and JP

Complianceonline

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process for obtaining federal government approval for marketing new animal drug products that are under the jurisdiction of the FDA, and also briefly covers animal products that are regulated by other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture, and some flea and tick control products are regulated by the Environmental Protection Agency.

This three-day interactive seminar will provide attendees with an understanding of FDA’s veterinary drug approval process. The group size is small, generally between 8 and 20 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.

FDA veterinary drug approval process, center for veterinary medicine, new animal drug application, investigational new animal drug (INAD) file, animal disease diagnostic devices, veterinary medicine regulations, veterinary drug user fees, Agriculture’s Animal and Plant Health Inspection Service, APHIS, NADA, FDA’s rules governing chemistry, animal field study, FDA compliant label, labeling, marketing, advertising, animal feed, veterinary devices, OTC drug products, FDA's product centers, Center for Food Safety and Applied Nutrition (CFSAN), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Tobacco Products, Center for Veterinary Medicine (CVM), environmental Impact (EA/CE), container Closure System, stability, Veterinary Clinical Trials, Animal Drug User Fees and Related Fee Waivers, 21 USC, 303 and 307

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.

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

Complianceonline

The objective of this two day ComplianceOnline seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program and how to maintain Quality Systems that minimize these issues. This seminar is designed to assist in assuring that your organization is maintaining itself within cGMP compliance. Case studies to include Warning Letters will be discussed to illustrate the wide array of issues that continue to arise and how to find them within your organization and your vendors before the regulators find them for you. This seminar represents a great opportunity for a team from your Corporation to attend and mutually benefit each other.

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

Complianceonline

Please join us for this intense one-day program that will give you the skills to succeed as a case manager or social worker in the new era of value-based reimbursement and accountable care. The world of healthcare is changing so rapidly and so is the role of case management in that world! Whether you are reading or hearing about value-based reimbursement, the Affordable Care Act, the continuum of care, bundled payments, transitions in care, or accountable care organizations, case management is at the center of it all!