Developing a Strategic Approach to FDA Compliance for Computer System Validation – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on Oct 10, 2018 | 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes | By: Carolyn Troiano

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You will learn how to take a strategic approach to validating computer systems that are regulated by FDA in a way that will be cost effective and efficient. The webinar will go through the System Development Life Cycle (SDLC) methodology in detail, and we will demonstrate how the SDLC supports Computer System Validation (CSV).

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these forms the basis for any CSV project. The importance of the sequence of steps will also be covered.

Why Should You Attend

An FDA inspection or audit is something to take very seriously, and it’s important to have all computer systems that are regulated by FDA fully validated. In this FDA Compliance training, you will learn how to validate computer systems in compliance with FDA’s guidelines and also how to maintain them in a validated state. This will provide you with a level of certainty that you will be able to respond to FDA questions and provide the documentation necessary to defend your approach and body of work.

Learning Objectives:

  • Learn about industry best practices related to compliance and computer system validation
  • Learn about strategies for reducing the cost and complexity of compliance with FDA regulations
  • Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
  • ….. and more

Session Highlights:

  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy that will take into account the system risk assessment process
  • ….. and more

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Use Coupon Code “FDA25” to get $25 Off.
Attend in a Group and save upto 50%. Email us at support@pioneereducator.com for bulk orders.

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on Oct 12, 2018 | 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes | By: Danielle DeLucy

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The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

Why Should You Attend

Failure to adequately assess and control your supplier/subcontractor pool can result in dire consequences for an organization. Assessing and approving your suppliers before placing the first order with them will eliminate many headaches for a medical device manufacturer.

Many organizations conduct supplier audits because they are required to do so by their customers or a regulatory agency. Others conduct the audits because they have been led to believe that it’s a good tool for comparing various suppliers against an arbitrary list of criteria.

While all of these reasons have varying degrees of validity, none of them articulate the best reason for having a robust supplier audit program. A good supplier audit program should allow an organization to assess and periodically re-affirm the ability of key suppliers to provide conforming product consistently, reliably and on-time. It should be one of the most important initiatives toward fulfilling the goal of having a sustainable supply chain.

Learning Objectives:

  • Understanding the FDA’s requirements for medical device supplier assessment and approvals
  • Learning “who” are considered to be suppliers
  • Knowing how to structure a supplier quality agreement
  • Selecting the potential methods for evaluating and assessing suppliers

Areas Covered in the Webinar:

  • Regulatory requirements for supplier qualification
  • Responsibilities of manufactures and suppliers
  • Best practices for supplier selection, qualification and management
  • What are the FDA’s expectations in regards to quality agreements?
  • What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?
  • Best practices for a good quality agreement
  • Supplier audits
  • Documentation requirements and audit trails

CLICK HERE TO REGISTER

Use Coupon Code “FDA25” to get $25 Off.
Attend in a Group and save upto 50%. Email us at support@pioneereducator.com for bulk orders.

Software & Technology II – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on Oct 17, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT | Duration: 60 Min 

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Software and technology touches virtually every aspect of the global food supply chain. The positive impact on time- and temperature-sensitive perishables is especially profound, helping to support longer and more complex supply chains, omnichannel grocery, regulatory compliance and recall events, to name a few.

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Foodservice Webinar – Hottest Food Supply Chain Trends in 2017

food-logistics-supply-chain

Hottest Food Supply Chain Trends in 2017

Join Food Logistics and a visionary panel of industry executives for an insightful discussion on the hottest trends and developments for 2017 and what they portend for your business. From the macro to the micro, the global to the granular, the goal is to highlight the key issues for 2017 and analyze the what, where, how and why’s they matter.

Date: Wednesday, December 07, 2016

Time: 12:00 PM Central Standard Time

Duration: 1 hour

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A FD&C Special Interest Group has been created for the Dallas and Fort Worth area ASQ members. It is our desire to have a local presence to help provide members with resources in the interpretation, and implementation of the regulated guidelines within Food, Drug, Supplement, and Cosmetic industries.

We welcome your participation as an attendee or presenter. If you have any questions, please contact Sharon McNair (mcnair_sharonmtex@outlook.com), ph: 214-300-1422.

Meeting Location
Mannatech, Incorporated
600 S. Royal Lane, Suite 200
Coppell, TX 75019

Contact

Sharon McNair
FD&C SIG Chair
mcnair_sharonmtex@outlook.com
(214) 300-1422

Click here for more information on the FD&C SIG.