Webinars

Streamlining Your Internal Auditing Process

Streamlining Your Internal Auditing Process

This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.
FDA's Ambitious Regulation of Social Media

FDA's Ambitious Regulation of Social Media

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.
Developing Practical and Successful GCP and GVP Audit & Inspection CAPAs

Developing Practical and Successful GCP and GVP Audit & Inspection CAPAs

This Webinar will focus on how to use SMART goals as a framework to draft submission-ready GCP and/or GVP CAPAs that not only adequately address observations but are also practical given your organization’s unique goals and challenges. Anecdotes and examples will be provided to lend context, and tools shared to give you the confidence to write successful CAPAs.
Implementing a GxP Quality Management System

Implementing a GxP Quality Management System

This 90-minute GxP Quality Management System webinar introduces you to the planning and implementation of a QMS using a pharmaceutical QMS as a working model and focuses on fundamental concepts of quality, managing quality, systems, processes, managing change and assessment tools.
Annual Current Good Manufacturing Practices (cGMP) Training

Annual Current Good Manufacturing Practices (cGMP) Training

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
The PSMF- Accountability, Inspection Preparation and Business Analytics

The PSMF- Accountability, Inspection Preparation and Business Analytics

This webinar will discuss the structure of the PSMF as per EU Directive 2010/84/EU and how adopting this document in the US will provide a transparent process for Accountability, Inspection Preparation and Business Analytics.
Raw Materials in Pharma/Biotech Production

Raw Materials in Pharma/Biotech Production

In the webinar, gain the skills for practical implementation of regulatory requirements for Pharma/Biotech raw material selection, receipt, testing, storage, and use in production.
Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program

Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program

This webinar will tell you what you need to know to design a compliant vendor program, implement it throughout the organization, manage the necessary documentation and effectively communicate with vendors your requirements, needs and issues.
State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs

State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs

This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a State-of-the-Art Library for your medical device portfolio.
Pharmaceutical Water System: Design, Testing and Data Management

Pharmaceutical Water System: Design, Testing and Data Management

In this pharmaceutical water system webinar attendees will learn how to design, validate and maintain the new and existing water systems used in drug product manufacturing process. Different types of routine tests, testing frequencies, actions in each tests and sampling procedures associated with pharmaceutical water systems will be discussed to avoid any water systems failures.
Using Kanban JIT Systems to Run a Startup Plant

Using Kanban JIT Systems to Run a Startup Plant

Attend this webinar to learn how to set up and use kanbans, JIT, pull system, and drum-buffer-rope in medical device and biotechnology manufacturing start-up operations. Also attendees will learn elements of lean documents and lean configuration, sterilization lot size, MRP II kanban system and how to use kanbans to track off-site sterilization and external supply chain suppliers.
Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
Lyophilization Process Development and Cycle Design with a Case Study

Lyophilization Process Development and Cycle Design with a Case Study

This webinar on Lyophilization Process Development and Cycle Design will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle.

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