WEBINARS

 

FDA Validation Requirements Regulatory Compliance Training - Live Webinars, Recordings & CDs

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Recording Available

* Per Attendee $299

 

Best Practices for an Effective Cleaning Validation Program

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 704329

This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.

Recording Available

* Per Attendee $299

 

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704086

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

Recording Available

* Per Attendee $349

 

Steam Sterilization Microbiology and Autoclave Performance Qualification

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 705027

In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

Recording Available

* Per Attendee $299

 

Implementation and Management of GMP Data Integrity

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 705029

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Recording Available

* Per Attendee $299

 

Implementing a Bullet Proof Quality System for FDA Audit Success

webinar-speaker   Meena Chettiar

webinar-time   60 Min

Product Id: 705400

This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.

Recording Available

 

Risk-Based Software V&V Per U.S. FDA, IEC 62304, GAMP 5 (Reg.) and ISO 14971

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701461

This software verification and validation training will discuss how to develop / implement formal software Verification and Validation methods for devices, production and test equipment and electronic records / signatures / Part 11 to meet regulatory / cGMP expectations, reducing the risk of 483 observations and Warning Letters. US FDA, Several standards and industry recommendations will be described in this V&V methods.

Recording Available

* Per Attendee $399

 

Sterilization of Pharmaceutical Products and Medical Devices

webinar-speaker   Carl Patterson

webinar-time   90 Min

Product Id: 705310

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.

Recording Available

* Per Attendee $299

 

21 CFR 11 Compliance for Excel Spreadsheet

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 702450

This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.

Recording Available

* Per Attendee $249

 

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 701242

This excel validation training / webinar will demonstrate how to design spreadsheets for Part 11/GxP /SOX/HIPAA compliance. And how to document planning, specifications, installation, testing and changes to meet FDA requirements.

Recording Available

* Per Attendee $299

 

Data Governance for Computer Systems Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 704745

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

Recording Available

* Per Attendee $249

 

Verification vs. Validation in FDA Regulated Industries

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 700828

This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Learn about the risks and complications involved with the application of sound verification and validation principles.

Recording Available

* Per Attendee $249

 

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 704848

A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.

Recording Available

* Per Attendee $249

 

Validation and Use of Cloud Computing in FDA Regulated Environments

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 703423

This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.

Recording Available

* Per Attendee $249

 

Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 701547

This webinar focuses on 21 CFR Part 11 requirements stipulated by the FDA. It will also guide attendees on writing corrective and preventive action plans as follow up to 483s.

Recording Available

* Per Attendee $249

 

Computer System Validation: Step-by-Step

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 701673

Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, and structure of validation report.

Recording Available

* Per Attendee $249

 

Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

webinar-speaker   John R Godshalk

webinar-time   60 Min

Product Id: 704806

This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity

Recording Available

* Per Attendee $249

 

Computer System Validation and Part 11 Compliance

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705427

This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.

Recording Available

 

Understanding and Implementing USP <1058>: Analytical Instrument Qualification

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 700067

This Analytical Instrument Qualification training will guide you through Understanding of draft for analytical instrument qualification - Essential steps and recommendations for firmware and software validation.

Recording Available

* Per Attendee $249

 

How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 705488

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

Recording Available

 

 

 

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