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martinlurthur

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Online Compliance Panel mainly focuses on providing quality training to compliance professionals on risk management, quality management, corporate governance and regulatory compliances. Others areas of focus encompass updates regarding modifications in regulatory affairs, best practices and industry trends. We provide fitting Solutions to your queries, help you get to know about new ideas and best practices, enable sharing of ideas and thought processes.Onlinecompliancepanelhttp://onlinecompliancepanel.com
martinlurthur's Documents
Showing 1 - 10 of 32

The Role of Lab Data in the Drug Development Process: Adverse Events and Subject Safety

by: martinlurthur, 2 pages

All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol.

Risk Management for Medical Devices: ISO 14971:2007

by: martinlurthur, 2 pages

The company is required to implement a risk management program as an integral part of its quality system. A robust risk management program identifies and manages hazards throughout the product ...

Lyophilization Process Development and Cycle Design

by: martinlurthur, 2 pages

This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle to improve the quality and consistency of the product while also reducing ...

IND Submission for a 505(b)(2) Product

by: martinlurthur, 2 pages

A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, ...

Improving 510(k) Submission Quality

by: martinlurthur, 2 pages

This webinar is intended to present various strategies and methods to improve 510(k) submission quality. A 510(k) premarket notification submission (“510(k)”) is made to US FDA.

How to Survive a DEA Inspection Series: Controlled Substances and Hospitals

by: martinlurthur, 2 pages

This training will cover several recommendations to improve the hospital's Due Diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and ...

How to Survive a DEA Inspection Series: Pharmacy Records and Security

by: martinlurthur, 2 pages

The public media has been reporting the fraud and abuse of narcotic dispensed for pain. Reports target the legitimacy of prescriptions and pharmacist who fulfill them. Federal and state regulations ...

How to Survive a DEA Inspection Series: Due Diligences of a Pharmacy

by: martinlurthur, 2 pages

The public media has been reporting the fraud and abuse of narcotic dispensed for pain. Reports target the legitimacy of prescriptions and pharmacist who fulfill them. Federal and state regulations ...

How to Survive a DEA Inspection Series: DEA Due Diligence for Manufacturers and Distributors

by: martinlurthur, 2 pages

The training will cover several recommendations to improve the Corporate Due Diligence when narcotic drugs are purchased by their customers and the steps that can be taken to detect and prevent the ...

How to Survive a DEA Inspection Series - For Manufacturers and Distributors

by: martinlurthur, 2 pages

The training will cover DEA record-keeping and security requirements that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced ...

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