All Adam Fleming online Events (47)

Statistical Analysis of Gages (Metrology)

February 19, 2020 from 10am to 1pm – Online The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the stan… Organized by Compliance4all | Type: online, event

Useful Statistical Methods for Defining Product and Process Specifications

February 17, 2020 from 10am to 1pm – Online Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions ove… Organized by Compliance4all | Type: online, event

FDA Audit Best Practices - Do's and Don'ts

February 14, 2020 from 10am to 1pm – Online This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory do… Organized by Compliance4all | Type: online, event

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

February 13, 2020 at 10am to April 13, 2020 at 1pm – Online This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Wha… Organized by Compliance4all | Type: online, event

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

February 12, 2020 from 10am to 1pm – Online 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 fol… Organized by Compliance4all | Type: online, event

Label Promotion of Drugs and Medical Devices

April 24, 2018 from 10am to 1pm – Online Overview:This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents. Why s… Organized by Adam Fleming | Type: online

How a Quality and Lean Steering Committee can be Effectively Utilized

April 20, 2018 from 10am to 11am – Online Overview:Attendees will observe the development of the key components of a steering committee. Several successful examples across various business types will be shared. Why should you Attend:This int… Organized by Adam Fleming | Type: online

ISO 62366 - How to Conduct a Human Factors

April 18, 2018 from 10am to 11am – Online Overview:This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. Why should you Attend:We will explain how to choos… Organized by Adam Fleming | Type: online
Failure Modes - How to use these Kinds of Methods Together

April 18, 2018 from 10am to 11:30am – Online Overview:This leads to an evaluation of the failure's effect on the product or process and measures to manage it. Often a criticality analysis augments the FMEA, creating an FMECA, to determine the p… Organized by Adam Fleming | Type: online

Understanding and Meeting your Regulatory & Processing Responsibilities

April 16, 2018 from 10am to 11am – Online Overview:Why DMFs are important to you and your company , and How DMFs fit into FDA's regulatory processes for review of drug and biologic applications. Areas Covered in the Session:Why DMFs are impo… Organized by Adam Fleming | Type: online