FDA Regulations and Guidance Training - Live Webinars, Recordings & CDs
- Speaker: Danielle DeLucy
- Product ID: 704499
- Duration: 60 Min
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. When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit the operation.
* Per Attendee
$199
- Speaker: Angela Bazigos
- Product ID: 703739
- Duration: 90 Min
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
- Speaker: Michael Simonian
- Product ID: 704528
- Duration: 60 Min
This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.
* Per Attendee
$199
- Speaker: Carolyn Troiano
- Product ID: 704745
- Duration: 60 Min
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
* Per Attendee
$199
- Speaker: Dr. Afsaneh Motamed Khorasani
- Product ID: 705583
- Duration: 60 Min
In this webinar you will gain a basic to moderate knowledge of definition, purpose, importance of GDP, General rules of GDP, GDP as applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029> introduction “Good Documentation Guidelines”, A very brief introduction to European Union (EU) GDP, and finally its enforcement along with some observation samples from FDA.
* Per Attendee
$199
- Speaker: Stephen Schwartz
- Product ID: 704516
- Duration: 105 Min
This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
* Per Attendee
$199
- Speaker: Charity Ogunsanya
- Product ID: 703885
- Duration: 90 Min
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
* Per Attendee
$199
- Speaker: Vanessa Lopez
- Product ID: 704409
- Duration: 60 Min
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
* Per Attendee
$179
- Speaker: Ginette M Collazo
- Product ID: 704210
- Duration: 90 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
* Per Attendee
$199
- Speaker: Vanessa Lopez
- Product ID: 704844
- Duration: 120 Min
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
* Per Attendee
$249
- Speaker: Ginette M Collazo
- Product ID: 704107
- Duration: 90 Min
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.
* Per Attendee
$199
- Speaker: Ginette M Collazo
- Product ID: 704314
- Duration: 90 Min
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.
* Per Attendee
$199
- Speaker: Ginette M Collazo
- Product ID: 704418
- Duration: 90 Min
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.
CD/Recorded
$249
- Speaker: John E Lincoln
- Product ID: 704848
- Duration: 90 Min
A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
CD/Recorded
$249
- Speaker: Danielle DeLucy
- Product ID: 705027
- Duration: 60 Min
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.
CD/Recorded
$249
- Speaker: Dr. Ludwig Huber
- Product ID: 703423
- Duration: 75 Min
This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.
CD/Recorded
$249
- Speaker: Wayland Rushing
- Product ID: 704685
- Duration: 60 Min
This training program will closely examine what are extractables and leachables. It will focus on how to design and implement leachable stability programs, including the requirements for leachable stability programs, developing and validating methods for use in leachable stability programs, and drug product impurities vs. leachable impurities.
CD/Recorded
$249
- Speaker: Danielle DeLucy
- Product ID: 704659
- Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
CD/Recorded
$249
- Speaker: Wayland Rushing
- Product ID: 704585
- Duration: 60 Min
This training program will detail the requirements for ICH stability studies, discuss how to design stability programs for your drug product, and list analytical methods requirements. It will also focus on how to interpret the data generated by the stability programs.
CD/Recorded
$279
- Speaker: Casper Uldriks
- Product ID: 703853
- Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
CD/Recorded
$279
