The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial. If you are involved in writing a clinical trial protocol, this seminar will provide valuable suggestions about various aspects of a clinical protocol from initial synopsis to various elements of the protocol, role of various personnel in finalizing the protocol, and troubleshooting common issues.
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 lifecycle. Once identified, hazards must be eliminated or mitigated to achieve the highest possible level of product safety and effectiveness. The company depends on its risk management program to continuously monitor and evaluate potential hazards associated with its products, and to take appropriate actions designed to lower the probability of harm to stakeholders.
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 the cycle time and associated costs. Optimized lyophilization cycle design can be an extremely difficult and daunting task for the scientist that is unskilled or under skilled in the process. This is becoming even more prevalent as many of the molecules coming out of discovery are more complex, unstable, and require a very specific, multi component formulation to impart not only good chemical stability and physical stability to the active ingredient, but also good physical stability to the dried solids themselves.
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. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begi n with "I agree".
There is an increasing frequency of real-time FDA Audits of trials and it seems that no one is well prepared. It is the obligation of the major players in the drug development process (the Investigator and the study Sponsor) to be sure studies are carried out correctly so that errors and mistakes are found and corrected by them (CAPA) and not by an FDA Investigator.
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, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. However, 505(b)(2) products require evidence from clinical trials conducted under an IND in support of the marketing approval application.
Class 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. Also they will be familiarized with the necessary documentation that should be noted in the patient chart and step to prevent diversion of the dispensed or prescribed drugs.
This webinar is intended to demonstrate how to navigate through hurdles during 510(k) processes and get it cleared from FDA. The premarket notification [510(k)], which is made to US FDA, is the most common pathway to market for medical devices. The 510(k) premarket submission is to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device). During the 510(k) processes, there could be lots of hurdles to overcome for clearance.
Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This seminar will provide step by step instructions to create SOPs for FDA-regulated organizations.
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. The section on "Safety monitoring" includes the array of lab tests taken at prescribed intervals adjudged to answer the safety questions. Whereas evaluation of this safety data is the Investigators responsibility, it is essential for the whole team and the sponsor to be on board with the timing and extent of this testing.
The public media has been reporting the abuse of narcotic drugs prescribed for pain management with its focus on the legitimacy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription.
Today's pharmacists will need to familiarize themselves with the stringent laws and regulations enforced by the Drug Enforcement Administration (DEA) through their Office of Diversion Control (Diversion).
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 inspection and the auditing methods.
All medical device manufacturers are required to comply with the complaint handling requirements and medical device reporting (MDR) pursuant to the applicable statutes and regulations.
This webinar is intended to help you get familiar with the best practices for the medical device complaint handling system. This webinar is also intended to provide guidance on how to meet the regulatory requirements for handling any complaints concerning all medical device types.
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 illicit use or diversion of any narcotic drug sold to customers.
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, serious injuries or deaths associated with medical devices to notify FDA of the incident.
MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. Device firms are also subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the procedures for MDR, recalls, corrections and removals.
A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).