Category: Special Interest Groups

Risk and Regulatory Compliance – 2018 Midwest FDC Conference

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Risk and Regulatory Compliance

Don’t miss the 2018 Midwest FDC Conference

October 3, 2018 at Wojcik Conference Center – Harper College

Palatine, Illinois

Regulatory authorities have embraced science-based risk management.  As the supply chain becomes more complex, risk awareness and quality aspects in general become more important.
All countries involved in regulated industries should have quality processes for sourcing of materials, manufacturing, packaging, testing, storage, and distribution.  These quality processes provide rationale to understand risk, as well as to mitigate it through appropriate and robust controls.

Members:  $100  Non-Members:  $120

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

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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

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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

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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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Lean 6-Sigma SIG – Monthly Meeting – 2018 September

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Topic:  An Introduction to TRIZ, The Theory of Inventive Problem Solving

Ever been stuck on a problem with no idea how to attack it? Or, come up with a solution that was just too complicated to implement? At this month’s meeting com learn about TRIZ (теория решения изобретательских задач), the Theory of Inventive Problem Solving. TRIZ is a systematic approach to understanding your problem, finding a solution, and simplifying complex designs. How you ask? Because through TRIZ you will learn that someone somewhere has already solved your problem.

Speaker Bio

John Ellis is currently Sr. Manager – Continuous Improvement and Strategic Project Portfolio, HR and Legal for NEC Corporation of America. He is a PMI certified PMP (Project Management Professional), an ASQ Certified Six Sigma Black Belt and a Textron Certified DFSS Black Belt and Master Black Belt. Prior to entering the world of Six Sigma he created and then managed the IT Project Management Office at Bell Helicopter. He has a long and varied IT background including managing data networks, IT product and vendor management, developing application architecture and standards, and operating systems programming. He is a graduate of the University of Southern California with a BA in Mathematics and German. John enjoys classical music and Broadway shows, plays piano, and is interested in foreign languages having studied French, Chinese Mandarin and American Sign Language in addition to his degree in German.

For more details: Calendar Event

Understanding BRC Global Standard for Food Issue 8 – Webinar

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

Live Webinar on Sep 06, 2018 | Duration: 60 Min | By: John Kukoly, Jennifer Lott

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This Webinar presented by SGS explores the newest version of BRC Global Standard for Food – Issue 8 and the changes included in the revision.

Objective
The objective of this webinar (45-minute presentation / 15-minute Q&A) is to bring awareness to food industry companies affected by the changes in the updates and revisions for the BRC Global Standard for food.

Agenda

  • Overview of BRC Global Standard for Food Issue 8
  • Key Changes to Issue 8
    • Food Safety Culture
    • Environmental Monitoring
    • Product Security and Food Defense
    • High Risk, High Care and Ambient High Care Production Risk Zones
    • Pet Food
  • Additional Modules – FSMA, Gluten Free, Food Safety & Quality Culture etc.
  • Issue 8 Timeline
  • How to Prepare and Get Ready
  • Q&A

Background

The focus of the newest version of BRC Global standard for food has been encouraging development of product safety culture. There has been an expansion of the requirements for environmental monitoring to reflect the increasing importance of this technique. Sites have been encouraged to further develop systems for security and food defense.

Issue 8 has added clarity to the requirements for high risk, high care and ambient high care production risk zones. Thus, providing greater clarity for sites manufacturing pet food and to ensure global applicability and GFSI benchmarking.

There will be a continued emphasis on management commitment. Hazard Analysis and Critical Control Point (HACCP) – based food safety program and supporting quality management system are recommended. And the implementation of good manufacturing practices within the production areas will add emphasis on areas which have traditionally resulted in recalls and withdrawals (e.g. label and packing management).

Presenters

John Kukoly

John Kukoly is the Americas Director for the BRC Global Standards team, responsible for the BRC programs throughout the America’s. The BRC Global Standard for Food Safety and the BRC Global Standards are regarded around the world as the leading food safety and quality certification program. John brings a wealth of experience and expertise to BRC and the GFSI technical working groups, with more than 20 years management experience in the food production and certification industry. He has had previous roles in quality, engineering and auditing.

Jennifer Lott

At SGS North America serves as a technical resource for GFSI approved auditing schemes, including FSSC 22000 food manufacturing, BRC Storage & Distribution, Packaging, and Consumer Products, RSPO, GMP/HACCP and is an accredited multi-sector Food Safety Program Lead Auditor and Trainer. Jennifer has over 25 years experience in quality assurance management, food safety management system development consulting, packaging, laboratory management, training and auditing. Jennifer holds a Bachelor of Science degree in chemistry from the College of Mount St. Joseph.

Target Audience
The webinar is aimed at Food Safety Quality Managers and Supervisors, Internal Auditors, Consultants, and those interested in learning more about BRC Global Standard for Food Safety Issue 8

Language: English
Cost: No Charge

If you can’t make a live session, please register in order to receive a complimentary recording after the live event.

CLICK HERE TO REGISTER

How FDA Evaluates Your Quality Management System – Webinar

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

Live Webinar on Jul 27, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT

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Unable to attend Live!!
Subscribe for Recorded

Short Abstract:

QSR imposes many requirements but contain little detail in how to implement them; however, failure to appropriately interpret these requirements could result in significant impact on your company, which may include temporary or permanent removal of your device from the market.

Areas Covered in the Webinar:

  • Introduction to FDA Regulations
  • Overview of Quality System Regulations (“QSR”)
  • How FDA Evaluates Your Quality Management System (“QMS”)
  • Most Inclusive Requirement: Document Control
  • Most Critical FDA Non-conformances
  • Most Common FDA Non-conformances

For More Information Kindly Click here or Copy and Paste Below Link http://www.biopracticee.com/webinar/live/154

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Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions – Webinar

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

Live Webinar on May 31, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT | Duration: 60 Min | By: Angela Bazigos

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Are you contain necessary component or you complete all step of 510(k) submission to allow consume Center resources?

The Office of Device Evaluation (ODE) receives approximately 6500 Premarket Notification (5100) submissions every year. Many of these submissions are incomplete or grossly inadequate, as they fail to contain the components necessary to allow substantive review of the submission and inappropriately consume Center resources. As a means to employ more effectively the Centers resources, the FDA has implemented procedures to ensure that 510Ks meet a minimum threshold of acceptability; otherwise the Center will refuse to accept the submissions for substantive review.

The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.

Our expert Angela Bazigos help you to understand the various cause of refusion to accept 510(k) Submissions.

Why should you attend:

In this webinar, you will learn what the FDA expects for a 510K submission. By following the principles outlined in this webinar, you will minimize the risk of your submission being rejected and you will increase the potential for a speedy review and approval by the agency.

Session Highlights:

  • FDA’s Guidance on Refuse to Accept
  • Pre-Submission Interaction
  • 510(K) Refuse to Accept Policies and Procedures High Level
    • the 510(k) Checklist
    • FDA Review Clock
    • Notification of Acceptance Review Result
  • Refuse to Accept Principles – Details
  • Refuse to Accept Checklist – Details
  • Acceptance Review Checklist  Details
  • Traditional vs Non-Traditional 510(K)s

 

CLICK HERE TO REGISTER

Use “FDA40” to get $40 Off.
Attend in a Group and save upto 50%. Email us at support@pioneereducator.com for bulk orders.