Webinar Search Results : 20 Upcoming webinars found.
Laura Brown Thursday, May 31, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials - are you Ready for Implementation for May 25th 2018?
Attain an understanding of the General Data Protection Regulation (GDPR).Be able to understand the key of the main tenets of GDPR which impact on clinical trials.

Joy McElroy Monday, June 4, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Joy McElroy
GLPs: How are they Associated with GMPs and SOPs
In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.

John C. Fetzer Monday, June 4, 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.

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
Data Integrity Compliance with 21 CFR Part 11 and SaaS/Cloud Software Applications
This webinar details the regulation and how it applies to computerized systems.

Dr. Ludwig Huber Monday, June 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Grace Morgan Holmes Monday, June 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Grace Morgan Holmes
Developing and Implementing Effective Corrective Action Plans in Clinical Trials
The concept of corrective and preventative actions (CAPA) are generally intertwined with the process of ensuring product quality in Good Manufacturing Procedures (GMP)- compliant manufacturing settings. This is because CAPA has been predominantly used to address identified errors and issues per regulatory requirements within the confines of current GMP (cGMP).

Sheldon Primus Tuesday, June 12, 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.

Angela Bazigos Wednesday, June 13, 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.

Angela Bazigos Thursday, June 14, 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.

Laura Brown Wednesday, June 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
How to Audit Against ICH GCP 2 Addendum to Ensure Compliance
It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year.

Dr. Ludwig Huber Wednesday, June 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

Angela Bazigos Wednesday, June 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Implement Good Clinical Practices for Successful FDA and International Regulatory Authority Inspections
This webinar will highlight the salient points of Good Clinical Practice and will enable the participants to understand how to implement GCP to achieve clinical trial best practices, best patient safety and/or successful FDA and international regulatory authority inspections.

Angela Bazigos Friday, June 29, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

Lauren Neighbours Monday, July 2, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Lauren Neighbours
Beginning with the End in Mind: Developing a Regulatory Strategy for Product Development
Today's biopharmaceutical companies are charged with making the most out of their limited resources (time, money, and personnel) to successfully bring products to market. Effective regulatory strategy, like product design, requires "quality-by-design" approach and planning throughout the product development lifecycle. For pharmaceutical, device, and biotechnology companies, understanding how to effectively design and manage a regulatory program can lead to more efficient product development and greatly increase the likelihood of marketing authorization.

Steven S. Kuwahara Tuesday, July 10, 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.

Angela Bazigos Tuesday, July 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Grace Morgan Holmes Tuesday, July 31, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Grace Morgan Holmes
Protocol Deviation Reporting and Management
Protocols are living documents that are often routinely amended throughout the life of a clinical trial. Due the ever-fluid nature of a protocol's evolution, as well as the potential errors and lack of clarity that they sometimes can possess, it is not surprising many of the issues cited in protocol audits and FDA inspections are noted protocol deviations and violations.

Carolyn Troiano Tuesday, August 7, 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.

Edwin Waldbusser Monday, September 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Edwin Waldbusser
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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