http://pressroom.prlog.org/onlinecompliance/onlinecompliancepanel Latest Press Releases http://www.prlog.org/12114240-how-to-conduct-successful-process-validation.htmlThis presentation covers a methodology that can be used for any oral product process...Mon, 08 Apr 2013 16:06:43 GMT http://www.prlog.org/12114208-case-studies-on-problem-cycles-and-or-formulations-of-lyophilized-products.htmlThis interactive webinar will cover several case studies in failed freeze-dried products due to poorly designed cycles, and or poorly designed...Mon, 08 Apr 2013 15:40:10 GMT http://www.prlog.org/12114019-medical-devices-regulation-by-online-compliance-panel.htmlMedical industry today is expanding at a rapid pace and producing enormous opportunities and businesses throughout...Mon, 08 Apr 2013 12:15:16 GMT 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).Thu, 21 Feb 2013 08:09:06 GMT http://www.prlog.org/12084307-medical-foods-practical-tips-to-meet-fda-requirements-for-claims-and-quality.htmlMedical foods play an important role in the management of patients with special dietary restrictions and needs.Thu, 21 Feb 2013 07:44:12 GMT 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.Thu, 21 Feb 2013 07:39:40 GMT 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.Thu, 21 Feb 2013 07:36:56 GMT http://www.prlog.org/12077108-bulletproofing-your-cgxp-documentation-from-audit-citations.htmlRegulators consider documentation to be a critical entity. Consequently, they always audit documentation systems and it is rare to find audits where 483s for poor documentation have not been issued.Mon, 11 Feb 2013 07:01:08 GMT http://www.prlog.org/12077102-the-impact-of-compliance-upon-your-industry-the-compliance-toolkit.htmlIn the document "Corporate Compliance Principles", developed by the National Center for Preventive Law.Mon, 11 Feb 2013 06:50:43 GMT http://www.prlog.org/12074383-online-compliance-panel-webinars-and-services.htmlThe medical device industry is characterized and mandated by compliances with government regulations. And, failure to adhere to stated stipulations lead to severe civil and legal liabilities.Wed, 06 Feb 2013 07:17:56 GMT http://www.prlog.org/12054522-quality-sops-guidelines-to-developing-and-writing-fda-compliant-documents.htmlClearly written, detailed Standard Operating Procedures (SOPs) are one of the key indicators of the caliber of regulatory compliance enforced by an organization.Mon, 07 Jan 2013 16:31:59 GMT http://www.prlog.org/12054507-use-gamp-to-surefire-your-csv-audit.htmlRegulatory agencies have stepped up audits to aggressively enforce computer systems validation (CSV) and CFR 21 Part 11/Annex 11 implementation.Mon, 07 Jan 2013 16:24:39 GMT http://www.prlog.org/12054504-history-of-fda-and-fda-regulations.htmlThis is a course that anyone in a hospital or clinic who might be involved in conducting a clinical trial should take.Mon, 07 Jan 2013 16:13:20 GMT http://www.prlog.org/12054467-computer-system-validation-webinar-by-online-compliance-panel.htmlComputer Validation is required by the GMP regulations and FDA has posted a Guidance Document on Electronic Signatures.Mon, 07 Jan 2013 15:32:29 GMT http://www.prlog.org/11968408-online-compliance-panel-best-practices.htmlThe medical device industry is characterized and mandated by compliances with government regulations. And, failure to adhere to stated stipulations lead to severe civil and legal liabilities.Tue, 11 Dec 2012 16:30:07 GMT http://www.prlog.org/11987961-writing-usfda-acceptable-clinical-trial-protocols.htmlThe clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial.Mon, 01 Oct 2012 11:39:13 GMT http://www.prlog.org/11987957-how-to-survive-dea-inspection-series-law-enforcement-and-pain-management.htmlClass participants will familiarize themselves with the federal laws and regulations enforced by DEA pertaining to Schedules II though V controlled substances that is dispensed, or prescribed by a physician as part of a pain treatment plan.Mon, 01 Oct 2012 11:03:51 GMT 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.Wed, 19 Sep 2012 10:27:48 GMT 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.Wed, 19 Sep 2012 10:07:18 GMT http://www.prlog.org/11961858-how-to-survive-dea-inspection-series-pharmacy-records-and-security.htmlThis presentation talk about the extensive amount of information provided on the DEA regulation requirements for any pharmacy or pharmacist for controlled substances that are purchased and dispensed in a form of a prescription.Wed, 29 Aug 2012 13:41:42 GMT http://www.prlog.org/11961828-best-practices-and-fda-compliant-medical-device-reports-mdrs-recall-corrections-and-removals.htmlIn the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions.Wed, 29 Aug 2012 12:58:12 GMT 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.Wed, 29 Aug 2012 12:41:38 GMT http://www.prlog.org/11951492-how-to-survive-dea-inspection-series-for-manufacturers-and-distributors.htmlThe training will cover DEA record-keeping and security requirements that DEA registrant must comply with when handling controlled substancesThu, 16 Aug 2012 15:26:40 GMT 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.Thu, 16 Aug 2012 15:21:14 GMT http://www.prlog.org/11942831-best-practices-for-establishing-compliant-medical-device-and-complaint-handling-system.htmlAll medical device manufacturers are required to comply with the complaint handling requirements and medical device reporting (MDR) pursuant to the applicable statutes and regulations.Mon, 06 Aug 2012 12:44:24 GMT 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.Fri, 13 Jul 2012 08:34:24 GMT 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.Fri, 13 Jul 2012 05:44:12 GMT 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.Thu, 12 Jul 2012 15:43:17 GMT