http://news.prlog.org/tag/regulatory-compliance-training/regulatory compliance training - Latest News (Press Releases) - Read news before it's newsen-us3600 http://www.prlog.org/12084311-trial-master-file-tmf-fda-expectations-from-sponsors-and-sites.htmlThe first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF). http://www.prlog.org/12084305-the-sunshine-act-reporting-for-clinical-trials.htmlPayments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare. http://www.prlog.org/12084303-meeting-the-fda-for-orphan-products-practical-strategies-to-maximize-benefit.htmlOrphan products have unique requirements for minimum testing to establish benefit to the target patients. http://www.prlog.org/11978472-ind-submission-for-505b2-product.htmlA 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug. http://www.prlog.org/11978458-510k-submission-and-clearance.htmlA premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. http://www.prlog.org/11961756-how-to-survive-dea-inspection-series-due-diligences-of-pharmacy.htmlThe public media has been reporting the fraud and abuse of narcotic dispensed for pain. http://www.prlog.org/11951476-fda-regulatory-control-of-the-drug-development-process.htmlWhen the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. http://www.prlog.org/11923549-how-to-survive-dea-inspection-series-dea-due-diligence-for-manufacturers-and-distributors.htmlDEA OFFICE OF DIVERSION CONTROL – familiarize the participant with the authority given to DEA when enforcing federal laws and regulations pertaining to controlled substances. http://www.prlog.org/11923436-the-role-of-lab-data-in-the-drug-development-process-adverse-events-subject-safety.htmlAll Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data. http://www.prlog.org/11922895-510k-submission-contents-and-format-for-medical-devices.htmlA premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. http://www.prlog.org/11818804-how-to-establish-an-effective-good-clinical-practice-in-drugs-and-medical-devices.htmlThis 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies http://www.prlog.org/11775292-statistical-considerations-for-ich-guidelines.htmlThis unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. http://www.prlog.org/11775276-understanding-and-implementing-the-medical-device-directive.htmlThe instructor addresses the details of the MDD and includes other significant issues such as the Quality Management System (ISO 13485), Risk Management (ISO 14971), Clinical Evaluation (MDD Annex X), and the role of harmonized standards. http://www.prlog.org/11648548-practical-cost-effectivehands-on-approach-to-implementing-risk-and-internal-controls-from-mana.htmlThis unique hands-on course will provide attendees with risk and control concepts as well as deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm. http://www.prlog.org/11648539-clear-as-mud-obtaining-marketing-your-510k-with-todays-fda-webinar-by-complianceonline.htmlAn interactive workshop to ensure you understand how to obtain a 510(k) in today's environment at FDA. http://www.prlog.org/11637810-decoding-clinical-laboratory-improvement-amendments-regulations-calibration-calibration-veri.htmlThe Clinical Laboratory Improvement Amendments (CLIA) training will outline the CLIA standards for frequency, methodology and also give examples of practical application. http://www.prlog.org/11633339-bioanalytical-methods-validation-webinar-by-complianceonline.htmlIn this Bioanalytical methods validation understand the Clear, Consistent and compliant approaches for instrumental, ligand binding, and cell based methods. http://www.prlog.org/11633305-analytical-method-lifecycle-from-design-and-development-through-validation-and-transfer.htmlThis 4hr training will offer a lifecycle approach to assuring analytical methods are suitable for their intended use. It will detail the stages of an analytical method and provide practical suggestions. http://www.prlog.org/11631906-auditing-the-qc-microbiology-laboratory-for-fda-compliance-webinar-by-complianceonline.htmlThis Microbiology Laboratory training provide a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection, potential areas for nonconformance,test failures,resolution of audit findings. http://www.prlog.org/11622150-full-day-virtual-seminar-addressing-impurities-in-pharmaceutical-products.htmlThis 7-hr webinar on Impurities in Pharmaceutical Products will provide a comprehensive overview of impurities which must be controlled in pharmaceutical products and the strategies for controlling them. http://www.prlog.org/11622143-how-to-survive-dea-inspection-series-dea-due-diligence-for-manufacturers-and-distributors.htmlThis 2-hr webinar on DEA Due Diligence will cover several recommendations to improve the Corporate Due Diligence when narcotic drugs are purchased by their customers. http://www.prlog.org/11622137-back-label-ingredient-statement-for-personal-care-cosmetics-what-why-and-how-to-inci.htmlThis 90-minute webinar on black-labeling for cosmetics will show how to prepare and file a request for a monograph of a tradename ingredient. http://www.prlog.org/11622133-how-to-survive-dea-inspection-series-for-controlled-substances-manufacturers-and-distributors.htmlThis 2-hr webinar will cover DEA record-keeping and security requirements that any DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods. http://www.prlog.org/11620862-best-documentation-practices-for-fda-compliance-webinar-by-complianceonline.htmlIn this FDA documentation best practices training for FDA regulated companies, learn the techniques ideas that will help identify effective methods designed to improve your document control systems. http://www.prlog.org/11620855-responding-to-fda-form-483s-and-warning-letters-webinar-by-complianceonline.htmlThis training on responding to FDA Form 483s and Warning Letters will present methods for reviewing, evaluating, and writing responses to FDA Form 483s and Warning Letters.