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How to Survive a DEA Inspection - Veterinary Medicine and Controlled Substances
Carlos M Aquino
90 Min
Product Id: 704885
This webinar will discuss federal laws on administering and dispensing veterinary medicine, penalties for non-compliance, DEA required records and effective methods to prevent unauthorized use of controlled substances.
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How to Conduct Successful Supplier Audits
Danielle DeLucy
60 Min
Product Id: 704499
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.
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Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations
Travis Austin MacKay
60 Min
Product Id: 705497
This online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.
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How to write SOP's that Avoid Human Error
Ginette M Collazo
90 Min
Product Id: 704418
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
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Root Cause Analysis - The Heart of Corrective Action
Betty Lane
75 Min
Product Id: 703391
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
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DEA, Your Registration and How to Lose It
Carlos M Aquino
120 Min
Product Id: 701992
This 2-hr webinar on DEA Due Diligence will cover several recommendations to improve the Corporate Due Diligence when controlled substances and regulated chemicals 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.
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Human Error Investigations, Root Cause Determination and CAPA Effectiveness
Ginette M Collazo
90 Min
Product Id: 704314
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
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Handling OOS Test Results and Completing Robust Investigations
Danielle DeLucy
90 Min
Product Id: 704351
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
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Best Practices for an Effective Cleaning Validation Program
Joy McElroy
60 Min
Product Id: 704329
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.
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How to Survive a DEA Inspection Series: Controlled Substances and Hospital Pharmacy
Carlos M Aquino
120 Min
Product Id: 701991
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 prevent the illicit use or diversion.
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Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
Joy McElroy
120 Min
Product Id: 704086
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
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Human Error Reduction in GMP Manufacturing
Ginette M Collazo
90 Min
Product Id: 704107
This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.
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Pack of 3 Trending Courses on USP Standards
Dr. Afsaneh Motamed Khorasani,Mark Powell,Dr. Ludwig Huber
3 Hrs
Product Id: 706719
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FDA Data Integrity Training: Pack of 6 Training Courses
John R Godshalk,Carolyn Troiano,Danielle DeLucy,Kelly Thomas
9 Hrs
Product Id: 706717
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Product Stability Testing Program - Designing and Sustaining New and Existing Programs
Charity Ogunsanya
90 Min
Product Id: 703000
This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
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Proper Execution of Annual Product Reviews
Danielle DeLucy
60 Min
Product Id: 704993
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
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Steam Sterilization Microbiology and Autoclave Performance Qualification
Danielle DeLucy
60 Min
Product Id: 705027
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
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Leveraging Metadata for SDTM Automation and Compliance
Sunil Gupta
90 Min
Product Id: 706569
This presentation reviews the six levels of metdata level processing that all organizations need to be aware of and plan for. In the current days of automation in our daily lives at home, in the car and in various industries, FDA submissions in the pharma industry is next in line for more automation through metadata. We will explore examples for each of the metadata level. Metadata will be reviewed to understand how metadata has answers to key questions for logical processing. SAS tools will be reviewed to write code for more automation process.
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Training and Development in The Life Sciences - Build Training That Works
Charles H Paul
60 Min
Product Id: 706542
This webinar will explore the area of training in regulated environments, its importance, and its relationship to compliance documentation. You will learn how to achieve world-class compliance, improved operational performance, improved quality, and improved employee/associate safety through training.
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An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use
Karl M. Nobert
90 Min
Product Id: 701927
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.