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The first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF).

Medical foods play an important role in the management of patients with special dietary restrictions and needs.

Payments 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.

Orphan products have unique requirements for minimum testing to establish benefit to the target patients.

Regulators 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.

In the document "Corporate Compliance Principles", developed by the National Center for Preventive Law.

The 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.

A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug.

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices.

This 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.

In 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.

The public media has been reporting the fraud and abuse of narcotic dispensed for pain.

The training will cover DEA record-keeping and security requirements that DEA registrant must comply with when handling controlled substances

When 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.

DEA OFFICE OF DIVERSION CONTROL – familiarize the participant with the authority given to DEA when enforcing federal laws and regulations pertaining to controlled substances.

All 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.

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices.

This 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

This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines.

The 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.

Our services are aimed at benefitting the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries.

This 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.

An interactive workshop to ensure you understand how to obtain a 510(k) in today's environment at FDA.

The Clinical Laboratory Improvement Amendments (CLIA) training will outline the CLIA standards for frequency, methodology and also give examples of practical application.

In this Bioanalytical methods validation understand the Clear, Consistent and compliant approaches for instrumental, ligand binding, and cell based methods.

This 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.

This 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.

This 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.

This 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.

This 90-minute webinar on black-labeling for cosmetics will show how to prepare and file a request for a monograph of a tradename ingredient.

This 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.

In 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.

This 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.