Webinar Search Results : 24 Upcoming webinars found.
Michael Abitz Thursday, April 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Michael Abitz
Fishbone Diagramming
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Sheldon Primus Friday, April 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Sheldon Primus
Laboratory Safety: Don't be Caught Unaware of Laboratory Hazards
In this webinar, we will explore the hazards related to the laboratory on many fronts. To understand the laboratory work environment as it relates to safety, the employer must consider what the materials the workers are exposed to on a daily basis.

Carolyn Troiano Friday, April 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Computer System Validation (CSV) for FDA-Regulated Computers
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

Peggy Berry Friday, April 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Peggy Berry
Complaint Handling
The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Angela Bazigos Thursday, April 26, 2018
12:30 PM PDT | 03:30 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Regulatory Compliance in the Pharmaceutical Supply Chain
One of the practical implications of the FDA's challenge is the restructuring of a company's supply chain. A company will need to manage its risks across products, technologies, and sites, and ensure that its drugs are safe at the point-of-use. This webinar will show the participant how to best achieve this to avoid adverse inspection results or harm to patients.

Dr. Ludwig Huber Monday, April 30, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Carolyn Troiano Tuesday, May 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Good Documentation Practices to Support FDA Computer System Validation
As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.

Angela Bazigos Wednesday, May 2, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Comply with 21 CFR 11 Requirements for Electronic Medical Records
The principles outlined in this webinar can be used for computerized systems that contain any data that are relied on by an applicant in support of a marketing application, including computerized laboratory information management systems that capture analytical results of tests conducted during a clinical trial. For example, the recommendations in this webinar would apply to computerized systems that create source documents (electronic records) that satisfy the requirements in 21 CFR 312.62(b) and 812.140(b), such as case histories.

Steven S. Kuwahara Thursday, May 3, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Steven S. Kuwahara
Auditing Analytical Laboratories for FDA Compliance
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Dr. Ludwig Huber Thursday, May 3, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Understanding and Implementing USP 1058 Analytical Instrument Qualification
This webinar will discuss all details and give strategies and case studies for easy implementation. The first version of USP <1058> has been released in 2008. Since then it has evolved to the global standard for analytical instrument qualification. In August 2017 a new revision has been released with many new requirements mainly addressing the needs of quality systems, e.g., risk based implementation, quality agreements between service/system providers and users, and regular reviews to ensure ongoing performance and more.

Angela Bazigos Friday, May 4, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Responding to FDA 483s and FDA Warning Letters
Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.

Marina Malikova Friday, May 4, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Marina Malikova
Fundamentals of Risk Management in Clinical Research
Besides being a new expectation by regulatory agencies under good clinical practices, Quality by Design (QbD) and Risk-Based Quality Management (RBQM) concepts are receiving attention on a world-wide basis. As the industry's utilization of risk-based monitoring continues to increase along with the development and expansion of the area of RBQM, the need for the integration of these two concepts becomes apparent.

Angela Bazigos Monday, May 7, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

John C. Fetzer Monday, May 7, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John C. Fetzer
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.

Lauren Neighbours Tuesday, May 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Lauren Neighbours
Understanding Regulatory Expectations for Diversity in Clinical Trials
In line with the push towards more patient-centric approaches to clinical development, regulatory agencies are committed to ensuring clinical studies enroll participants that reflect the demographics of the target indication and patient population for the to-be-marketed product. This presentation will explore current regulatory expectations surrounding diversity inclusion in clinical research and provide insight on potential strategies to meet these expectations in your development program.

Angela Bazigos Thursday, May 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's Enforcement of 21 CFR Part 11 Compliance
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

David Nettleton Thursday, May 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: David Nettleton
Excel Spreadsheets - Step-By-Step Instructions for Compliance
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

Steven S. Kuwahara Wednesday, May 16, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Steven S. Kuwahara
GMP Expectations for Products Used in Early Phase IND Studies
FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Richard Chamberlain Thursday, May 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Richard Chamberlain
What is Computer Systems Validation?
The course will cover the history of Computer Systems Validation from the late 1970's to today. We will start with Process Validation and Qualification. Validation played a role in the GXPs, all three. The GMP was the furthest along, followed by the Laboratory practices, and finally the Clinical Research areas.

George Gasparis Friday, May 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: George Gasparis
Investigator Reporting Responsibilities: AEs, Unanticipated Problems, Modifications, and Deviations
This webinar will provide a comprehensive review of FDA and Office for Human Research Protections (OHRP) reporting requirements for investigators. A comparison will be provided for the AE reporting requirements for drugs and devices.

Angela Bazigos Friday, May 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3 Hours Boot Camp on Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds
This presentation uses the latest FDA thinking and guidance documents to assist you in re-establishing those requirements that need to be fulfilled in the evaluation for microbial methods used in your testing laboratories. It also re-establishes performance evaluation (verification & validation) criteria, necessary for the use of commercially-available diagnostic test kits and platforms.

Sheldon Primus Friday, May 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Sheldon Primus
Manufacturing Safety: What you don't Know can Harm you
In this webinar, we will explore the hazards related to the manufacturing facility on many fronts. To understand the plant work environment as it relates to safety, the employer must consider what the equipment the workers are exposed to on a daily basis.

Laura Brown Friday, June 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
Oversight of CROs-Vendors-CMOs
It is essential for industry to employ efficient and accurate strategies for monitoring outsourced projects to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, and quality monitoring and risk minimization when outsourcing activities in GXP areas to remain compliant.

David Nettleton Friday, June 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: David Nettleton
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This webinar details the regulation and how it applies to computerized systems.

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