Webinars

Ethylene Oxide and Gamma Radiation Sterilization Validations

Ethylene Oxide and Gamma Radiation Sterilization Validations

Gamma and EO Sterilization verification and validations under the U.S. FDA and EU's EMA / MDR requirements
Preparing for Pre-Approval Inspections

Preparing for Pre-Approval Inspections

A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug application is capable of consistently manufacturing a safe drug product, and that the submitted data is accurate and complete against what was filed in their application. This training will provide guidance on when the FDA performs pre-approval inspections. It will describe how to prepare for a PAI, and the outcomes of pre-approval inspections.
Ethylene Oxide (EO) Sterilization Basics for R&D Engineers

Ethylene Oxide (EO) Sterilization Basics for R&D Engineers

This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.
Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle. Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.
21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures

21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.
Mapping a Pharmaceutical Ingredient Bulk Manufacturing Workflow

Mapping a Pharmaceutical Ingredient Bulk Manufacturing Workflow

Mapping and evaluating all the steps in a current pharmaceutical ingredient bulk manufacturing workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.
Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance

Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance

The objective of this interactive, live training webinar is to explore the management of OOS practices and suggested avenues to take to minimize deviations, OOT, OOS and CAPA and how to attack these situations should they occur. It is also designed to determine how FDA and ICH regulations and guidances may impact them. It will also reference the new PDA TR 88, “Microbial Data Deviation Investigations in the Pharmaceutical Industry”.
Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485  7.3

Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3

Proper adherence and documentation of the FDA's Design Control requirements are key to any medical product project's success.
AI, ML & FDA Compliance for Computer Systems & Data

AI, ML & FDA Compliance for Computer Systems & Data

During the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.
Designing and Implementing an Effective Quality Management System (QMS)

Designing and Implementing an Effective Quality Management System (QMS)

Implementing a Quality Management System (QMS) involves a structured process to ensure consistent quality across an organization's operations. It typically starts with understanding the organization's context, defining policies and objectives, mapping key processes, and then implementing, monitoring, and continuously improving the system. The implementation process can vary based on the organization's size and complexity, but generally takes 3-18 months depending on an organization’s size.
The 6 Most Common Problems in FDA Software Validation and Verification

The 6 Most Common Problems in FDA Software Validation and Verification

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
Mapping and Review of Pharmaceutical Manufacturing and Packaging Workflows

Mapping and Review of Pharmaceutical Manufacturing and Packaging Workflows

Mapping and evaluating all the steps in a pharmaceutical manufacturing and packaging workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.
Stability Studies and Estimating Shelf Life

Stability Studies and Estimating Shelf Life

The webinar will provide useful methods and techniques for conducting a stability study and analyzing the resulting data for the purpose of estimating shelf life. Participants should be able to immediately apply the methods presented. Also, the interpretation and communication of results will be stressed and illustrated in several examples.
Effective Systems for Change Control in the Pharmaceutical Industry

Effective Systems for Change Control in the Pharmaceutical Industry

This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.
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.
US Market Access & Reimbursement :  Medical Devices

US Market Access & Reimbursement : Medical Devices

This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device
Analytical Method Development, and Method Transfer

Analytical Method Development, and Method Transfer

The U.S. FDA and EU's MDR require specific steps to be fulfilled to develop and/or transfer analytical methods to maintain accuracy.
Understanding and Preparing for FDA Pharmaceutical Inspections

Understanding and Preparing for FDA Pharmaceutical Inspections

This webinar will focus on the current trends in FDA Inspections and guidelines and how this information can be utilized to provide a foundation for compliance with the latest quality and regulatory requirements. Attendees will learn how to proactively prepare for an inspection.
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