Unique Device Identification (UDI) Final Rules Overview

Scheduled On : Wednesday, November 6, 2013 at 10 AM PST | 1 PM EST
Duration : 60 Minutes

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Description :

This webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules, finally issued on September 24, 2013.

This webinar is further intended to help you effectively implement a unique device identification (UDI) system (UDI system).  In particular, new changes in the final rules will be discussed, helping to save you an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.

In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution.
According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement.  The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology.
If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself.

The speaker will present how to implement the UDI system requirements in a CAC-SI manner.

Areas Covered in the Session :

• Applicable Statute(S), Regulations and Enforcement Authority
• Definitions
• UDI Development History
• UDI Final Rules: Technical Requirements and Changes Made
• When to Use a UDI and When to Discontinue Its Use
• UDI System Requirements including Technical Standards
• Requirements for a Unique Device Identifier
• FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
• UDI Rules: Applicability
• UDI Rules: Exceptions and Alternatives
• Compliance Dates for the Applicable Requirements Over Seven (7) Years
• Device Identifier Formats including Dates
• Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
• Impact of the Final Rules to Many Business Areas/Processes
• Changes in Device Design, Documentation and Manufacturing Processes
• Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast
• Conclusion

 

Who Will Benefit: 

• R&D Scientists, Managers, Directors, and VPs
• Regulatory Affairs and Compliance Professionals
• Clinical Affairs Professionals
• Quality Professionals
• Consultants
• Legal and Compliance Officers
• Marketing Professionals
• Senior Management
• Anyone Interested in the Subject

Speaker Profile

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Cleaning Validations Using Extraction Techniques

Scheduled On : Monday, November 4, 2013 at 10 AM PST | 1 PM EST
Duration : 60 Minutes

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Description :

Medical device manufacturers have always been under scrutiny to ensure that their product does no harm to the patient.  Regulatory agencies have become increasingly aware of the potential dangers of residual manufacturing materials on medical devices.  Therefore, cleanliness has become a hot topic in the medical device community.  A thorough validation of the cleaning processes used to remove residual materials from newly manufactured medical devices is necessary to ensure patient safety.One of the most common methods is using extraction techniques to validate the cleanliness of a device.

This 60 minutes webinar will provide in-depth and valuable guidance on how to achieve a thorough validation of a cleaning process.

Areas Covered in the Session :

• Cleaning Validation Overview
• Defining the Scope
• Identifying the Contaminants
• Choosing the Test Method
• Choosing the Solvents
• Setting Extraction Parameters
• Validating the Extraction
• Setting Limits

 

Who Will Benefit: 

• QA/QC managers and personnel
• Validation managers and personnel
• Manufacturers of Implantable Medical Devices
• Manufacturers of Single-Use Medical Devices
• Manufacturers of Reprocessed/Reusable Medical Devices

Speaker Profile

Kierstan Andrascik, founder of QVET Consulting, with her years of experience in the medical device industry assists manufacturers with their validation needs. She specializes in cleaning validations for both new and reprocessed medical devices and has established herself as one of the foremost experts in medical device cleanliness. She also provides guidance in many other areas including sterilization, biocompatibility, packaging, and materials characterization. Previously, she worked at Nelson Laboratories in Salt Lake City, Utah where she served as study director covering a variety of testing including new device cleaning validations, materials characterization, and package testing.

In 2002, she began developing a method to quantify residual manufacturing materials on medical devices. In 2005, ASTM published a similar method as F2459. Kierstan has been actively serving on the ASTM Device Cleanliness subcommittee since 2005. She received a Certificate of Achievement from ASTM in May 2007. In the June 2008 issue of Medical Design magazine, her article titled "How to tell if a device is really clean" was published. Then, in April 2011, her chapter “Cleaning Validations using Extraction Techniques” published in the 2nd edition of Handbook for Critical Cleaning. She has a BS in chemistry and mathematics, and an AS in Engineering from Shepherd University in Shepherdstown, West Virginia.

21 CFR 11 Compliance for Excel Spreadsheets

Scheduled On : Tuesday, October 22, 2013 at 10 AM PDT | 1 PM EDT
Duration : 120 Minutes

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Description :

In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings.

Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

Areas Covered in the Session :

• Requirements for Excel Spreadsheets
• FDA Part 11 Validation Guidance
• Compliance Problems with Spreadsheets
• Design Specifications for 21 CFR 11 compliance
• Documentation for Part 11
• Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

 

Who Will Benefit: 

• Quality Managers
• Quality Engineers
• Small business owners
• GxP
• Consultants
• Quality VPs
• IT VPs

Speaker Profile

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Life science industry

Robust Verification and Validation

Scheduled On : Wednesday, October 16, 2013 at 10 AM PDT | 1 PM EDT
Duration : 90 Minutes

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Description :

This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning.

And now the FDA is taking an even tougher stance.

Why do companies need robust V&V?
What are the "must have" elements from  the cGMPs?
How do ISO 14971 and ICH Q9 for hazard analysis and product risk management factor in and assist to allocating limited company resources?
How can these be integrated into the company's quality management system?

Areas Covered in the Session :

• Robust Verification and Validation -- Recent Regulatory requirements.
• The Master Validation Plan(s).
• Individual Verification and Validation Plans and their execution.
• Product Verfication & Validation.
• Process and Equipment Verfication & Validation, including Software.
• QMS V&V and 21 CFR Part 11.
• When and How to Use DQ, IQ, OQ, PQ, or ASTM E2500 Equivalents.
• The 11 Elements of the FDA's Software VT&V "Model".
• Incorporate the Hazard Analysis / Risk Management tools of ISO 14971 and ICH Q9.
• Avoid recent compliance problems.

 

Who Will Benefit:

 

This webinar will provide valuable assistance to all regulated companies that need to review and modify their company's planning and execution of verification and validation. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The professionals who will benefit include all:

• Senior management
• Middle management
• R&D
• Engineering
• Software
• QA / RA
• Manufacturing
• Operators
• Consultants
• cGMP instructors

And all personnel involved in verification and/or validation planning, execution and documentation.

Speaker Profile

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

Acceptance Activities in FDA Quality Systems Regulation

Scheduled On : Thursday, October 10, 2013 at 10 AM PDT | 1 PM EDT
Duration : 90 Minutes

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Description :

For device company Warning Letters in 2012, Acceptance Activities, 820.80, was the fourth most frequently cited QSR section. The trend continues in 2013. Not only are acceptance activities important for themselves, they link to many other QSR sections.

Acceptance activities can be hidden problems, waiting for an FDA Inspection to surface them. You don’t need to worry if you implement a solid program. This webinar guides you through the five subsections of 820.80 acceptance activities and explain how they integrate with other parts of QSR.


Level : Intermediate

Areas Covered in the Session :

Attendees of Acceptance Activities will:

• Develop an understanding of the parts of acceptance activities
• Learn how to document acceptance activities as part of the 820.20(d) quality plan
• Understand how to apply statistical techniques, especially sampling plans, to acceptance activities
• Understand the fundamental linkage between purchasing controls and receiving acceptance
• Understand how acceptance activities support the DMR and provide data for the DHR

 

Who Will Benefit:

 

This webinar is a must for professionals in the device industry, including:

• Quality Engineers
• Production Managers
• Production Supervisors
• Quality Assurance and Quality Control
• Quality Inspection and Test Managers
• Purchasing Managers
• Regulatory Affairs
• Supply Chain Specialists

 

Speaker Profile

Dan O'Leary, President, Ombu Enterprises, LLC, has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.