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

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706938

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.

28 / Jul / 2025 - Monday

* Per Attendee $189

 

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

webinar-speaker   Carolyn Troiano

webinar-time   90 Mins

Product Id: 707014

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.

30 / Jul / 2025 - Wednesday

* Per Attendee $199

 

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

webinar-speaker   David Nettleton

webinar-time   90 Mins

Product Id: 701687

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).

5 / Aug / 2025 - Tuesday

* Per Attendee $229

 

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

webinar-speaker   Steven Wachs

webinar-time   75 Mins

Product Id: 705020

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.

7 / Aug / 2025 - Thursday

* Per Attendee $189

 

Mapping a Pharmaceutical Ingredient Bulk Manufacturing Workflow

webinar-speaker   Michael Esposito

webinar-time   90 Mins

Product Id: 707020

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.

12 / Aug / 2025 - Tuesday

* Per Attendee $199

 

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

webinar-speaker   Barry A Friedman

webinar-time   90 Mins

Product Id: 706884

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”.

18 / Aug / 2025 - Monday

* Per Attendee $199

 

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

webinar-speaker   John E Lincoln

webinar-time   90 Mins

Product Id: 706923

Proper adherence and documentation of the FDA's Design Control requirements are key to any medical product project's success.

19 / Aug / 2025 - Tuesday

* Per Attendee $199

 

AI, ML & FDA Compliance for Computer Systems & Data

webinar-speaker   Carolyn Troiano

webinar-time   90 Mins

Product Id: 707021

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.

25 / Aug / 2025 - Monday

* Per Attendee $199

 

Designing and Implementing an Effective Quality Management System (QMS)

webinar-speaker   Joy McElroy

webinar-time   90 Mins

Product Id: 707022

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.

28 / Aug / 2025 - Thursday

* Per Attendee $199

 

Useful Statistical Methods for Defining Product and Process Specifications - Part I

webinar-speaker   Steven Wachs

webinar-time   75 Mins

Product Id: 706897

This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications. Appropriate product specifications are critical to achieving adequate and reliable product performance.

5 / Sep / 2025 - Friday

* Per Attendee $199

 

The 6 Most Common Problems in FDA Software Validation and Verification

webinar-speaker   David Nettleton

webinar-time   120 Mins

Product Id: 705582

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.

9 / Sep / 2025 - Tuesday

* Per Attendee $249

 

US FDA's AI Framework for Medical Devices

webinar-speaker   John E Lincoln

webinar-time   90 Mins

Product Id: 706934

The ability of artificial intelligence / machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices. The FDA recognizes AI's advantages and dangers and has started to outline its expectations of industry and device design, programming, unique validation issues, documentation and submissions.

10 / Sep / 2025 - Wednesday

* Per Attendee $199

 

Mapping and Review of Pharmaceutical Manufacturing and Packaging Workflows

webinar-speaker   Michael Esposito

webinar-time   90 Mins

Product Id: 707023

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.

15 / Sep / 2025 - Monday

* Per Attendee $199

 

Calculations for Process and Product Capability

webinar-speaker   Elaine Eisenbeisz

webinar-time   120 Mins

Product Id: 706629

Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the various types of process data (attribute or variable).

18 / Sep / 2025 - Thursday

* Per Attendee $219

 

Useful Statistical Methods for Defining Product and Process Specifications - Part II

webinar-speaker   Steven Wachs

webinar-time   75 Mins

Product Id: 706898

This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications. Appropriate product specifications are critical to achieving adequate and reliable product performance.

19 / Sep / 2025 - Friday

* Per Attendee $199

 

Ethylene Oxide and Gamma Radiation Sterilization Validations

webinar-speaker   John E Lincoln

webinar-time   90 Mins

Product Id: 707018

Gamma and EO Sterilization verification and validations under the U.S. FDA and EU's EMA / MDR requirements

Recording Available

* Per Attendee $249

 

US Market Access & Reimbursement : Medical Devices

webinar-speaker   Robert J Russell

webinar-time   60 Min

Product Id: 706989

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

Recording Available

* Per Attendee $219

 

Analytical Method Development, and Method Transfer

webinar-speaker   John E Lincoln

webinar-time   90 mins

Product Id: 707009

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

Recording Available

* Per Attendee $219

 

Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies

webinar-speaker   Elaine Eisenbeisz

webinar-time   90 mins

Product Id: 706650

This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.

Recording Available

* Per Attendee $249

 

Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment

webinar-speaker   Gerry O Dell

webinar-time   90 Min

Product Id: 701929

This training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98.

Recording Available

* Per Attendee $249

 

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