Risk and Regulatory Compliance
Don’t miss the 2018 Midwest FDC Conference
October 3, 2018 at Wojcik Conference Center – Harper College
Palatine, Illinois
Members: $100 Non-Members: $120
Don’t miss the 2018 Midwest FDC Conference
October 3, 2018 at Wojcik Conference Center – Harper College
Palatine, Illinois
Members: $100 Non-Members: $120
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
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:
Session Highlights:
Live Webinar on Oct 12, 2018 | 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes | By: Danielle DeLucy
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:
Areas Covered in the Webinar:
Live Webinar on Oct 17, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT | Duration: 60 Min
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.
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.
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.
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Live Webinar on Sep 06, 2018 | Duration: 60 Min | By: John Kukoly, Jennifer Lott
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
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.
The monthly Lean 6-Sigma SIG Meeting form September 2018 onward will be held on the 3rd Thursday of each month.
Next meeting on 20th September.
The Time and Location remain unchanged.
Time:
6:30 pm – 8:00 pm
Location:
NEC Americas
3929 W John Carpenter Fwy
Irving, TX 75063
Live Webinar on Jul 27, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT
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:
For More Information Kindly Click here or Copy and Paste Below Link http://www.biopracticee.com/webinar/live/154
Live Webinar on May 31, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT | Duration: 60 Min | By: Angela Bazigos
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: