This holiday season, Lock up your medicines to protect children and teens

The holiday season brings guests of all ages into your home, so it’s an especially important time to make sure your medications are locked away safely in order to prevent accidental poisonings in children and misuse by teens. Hospitalizations and even deaths from medications meant for someone else are growing problems among kids and teens.

Children and teenagers can get into medications that can be dangerous and how to lock them up securely. Each year, thousands of children and teens are hospitalized because they've taken medications that have not been properly secured. 

A child may discover a pill box or a package of cold medicine on a bathroom counter, mistaking them for candies because of the attractive colors.

A teenager may take pills out of a medicine cabinet or a purse to experiment. Ever heard of "Pharm Parties" ? These are parties where in teens get together to share the prescribed medicines with their friends. Tragically, these scenarios are not uncommon, but they can be prevented.

Protect your loved ones this holiday season by locking away your prescription and over-the-counter medications before they wind up in the wrong hands. It’s a small step that can save a life.

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Improvements To The Medical Device Recalls Database

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) recently announced improvements to several public databases that will increase access to safety information on marketed medical devices. The improvements include adding new fields to the Medical Device Recalls database disclaimer icon and providing links to the recall database from FDA’s 510(k) Premarket Notification disclaimer icon and Premarket Approval (PMA) disclaimer icon  databases.

Specifically:

• The 510(k) and PMA databases will have a CDRH Recalls hyperlink at the bottom of each record if there are recalls associated with that medical device.
• The recalls database has been expanded to include recall status (whether or not the recall has been terminated), product classification (product code), premarket submission numbers associated with the recall (510(k)s and PMAs only), and the root cause of the recall as determined by the FDA. Also, the previously available field "Reason for Recall" has been renamed "Manufacturer Reason for Recall" to better clarify the source of the information.
• In addition to the new and renamed fields, two new links are available at the bottom of recall records. The first will search the Total Product Lifecycle (TPLC) database for additional information regarding other devices with the same product code as the recalled device. The other will search the premarket databases for other premarket submissions of this type of product from the same applicant. This will provide information about submissions cleared or approved after the recall.

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Breast Cancer Screening - Nipple Aspirate Test Is Not An Alternative To Mammography

What is a nipple aspirate device ?

It is a type of pump used to collect fluid from a woman's breast. A nipple aspirate test can determine whether the fluid collected from the breast contains any abnormal cells.

Certain manufactures are promoting the use of nipple aspirate tests as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming they are an alternative to biopsy or mammography. They also claim that a nipple aspirate test can detect pre-cancerous abnormalities and diagnose breast cancer before mammography with just a sample of a few cells.  The FDA is concerned that women will believe these misleading claims about a nipple aspirate test and not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences.

Possible health consequences include false negative test results, indicating the absence of breast cancer when cancer exists, and false positive test results, indicating the presence of breast cancer when none exists.  False negative results may lead to delayed diagnosis and/or delayed treatment of breast cancer, with increased risk of serious illness or death.  False positive results may lead to needless patient anxiety, along with unnecessary additional testing and treatment.

The FDA is alerting the public, including women and health care providers, that a nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer.  The FDA is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease.

The FDA, other public health agencies, and national medical and professional societies agree that mammography is the most effective method for detecting breast cancer in its earliest, most treatable stages.  These organizations include the American Cancer Society, the American College of Radiology, the Centers for Disease Control and Prevention, the National Cancer Institute, and the Society for Breast Imaging. The National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and it should not be used as a breast cancer screening technique.

What Health Care Providers are recommended:

• Do not use a nipple aspirate test as a substitute for mammography or by itself for breast cancer screening or diagnosis.

What Patients are recommended:

• Remember that a nipple aspirate test, such as Atossa Genetics Inc.'s Mammary Aspiration Specimen Cytology Test (MASCT) and/or ForeCYTE Breast Health Test systems, or the HALO Breast Pap Test, is not a substitute for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself for breast cancer screening or diagnosis.
• If you have had a nipple aspirate test as a stand-alone evaluation tool for screening and diagnosing breast cancer, you should request a mammogram from your health care provider to get accurate results.
• Undergo regular mammograms according to screening guidelines or as recommended by your health care provider.

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Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements

Scheduled On : Wednesday, December 4, 2013 at 10 AM PST | 1 PM EST
Duration : 90 Minutes

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Description : 

This webinar will discuss the Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new components to network, back-up of data, access control, rules for passwords, and audit trails. Case studies will be used to highlight common issues and potential solutions.

21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides the basic framework for computer systems used to generate records and data used for analysis and presentation. However, for any organization trying to understand and implement Part 11 requirements, there are only two options: One, hire expensive consultants and purchase expensive software, or implement self-created systems and live in constant fear of findings of non-compliance during FDA audits. In this seminar, we will simplify the regulatory requirements and add practical tips for quick and easy verification of compliance with FDA requirements which can be self-implemented by most organizations with minimum technical expertise.

Areas Covered in the Session :

• Part 11 requirements by FDA
• Applicable systems per the FDA
• Validation of computer systems
• Network set-up, maintenance, integrity check and security
• Common elements of Part 11 complaint computer systems
• Building Part 11 compliant systems bottom-up and top-down.
• Back-up and re-creating data
• Verifiable audit trails
• Electronic signatures and certificates
• Best practices for using non-networked computers

Who Will Benefit: 

This webinar will provide valuable information to:

• FDA-regulated labs, clinical trial sites, manufacturers, and sponsors
• Everyone involved in computer system validation
• Anyone selecting computer systems intended for FDA regulated environments
• Information technology professionals responsible for files or network locations
• Quality professionals who organize, document and verify system compliance
• Executives evaluating requirements Part 11 compliant systems

Speakers Profile

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multinational project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

and..
Herman Wong is a Washington DC-based consultant for computer systems in FDA-regulated industry. He has been in the industry for over 12 years and leads the Information Technology department at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in training of IT personnel in FDA-regulated industry, creating, managing and implementing Part 11 compliant computer systems. Since 2005, Mr. Wong has been evaluating EDC systems for Part 11 compliance at small and big organizations including some of the largest US federal organizations and large pharmaceutical companies.

Compliance Update: FDA approves medical device to treat epilepsy

The U.S. Food and Drug Administration approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.

The RNS Stimulator consists of a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two wires (called electrodes) that are placed where the seizures are suspected to originate within the brain or on the surface of the brain.

Epilepsy produces seizures affecting varied mental and physical functions. Seizures happen when clusters of nerve cells in the brain signal abnormally, which may briefly alter a person's consciousness, movements or actions. According to the Epilepsy Foundation, epilepsy affects nearly 3 million people in the United States and is the third most common neurological disorder, after Alzheimer’s disease and stroke. Approximately 40 percent of people with epilepsy are severely affected and continue to have seizures despite treatment.

The FDA’s approval is supported by a three-month randomized control trial of 191 patients with drug-resistant epilepsy.

The study showed that by three months after the implanted device was turned on (active use) patients experienced a nearly 38 percent reduction in the average number of seizures per month, compared to an approximately 17 percent reduction in the average number of seizures per month in patients who had the implanted device turned off. At the end of three months, the median reduction in seizures, which reflects a more typical patient experience, was 34 percent with active use and about 19 percent with the device turned off. During the trial, 29 percent of patients with an active device experienced at least a 50 percent reduction in the overall number of seizures, compared to 27 percent for those with the implanted device turned off.

During a two-year follow-up phase (unblinded), data demonstrated a persistent reduction in seizure frequency.

Patients with RNS Stimulators cannot undergo magnetic resonance imaging (MRI) procedures, nor can they undergo diathermy procedures, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS). The energy created from these procedures can be sent through the neurostimulator and cause permanent brain damage, even if the device is turned off.

The most frequent adverse events reported were implant site infection and premature battery depletion.

Source: FDA

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FDA slaps 'deadly' tag on Atossa's cancer Dx recall

The FDA has applied its most serious label to Atossa Genetics' ($ATOS) recall of a breast cancer diagnostic, warning that using the unapproved devices could lead women to forego treatment and increase their risk of serious injury and death.

Atossa voluntarily recalled the ForeCYTE Breast Health Test last month after a February FDA warning letter chided the company for marketing its system without agency clearance. Atossa billed its test as a tool to determine patients' cancer risk by screening small amounts of nipple aspirate fluid, but the company never secured the FDA's backing for those claims.

Now, the agency has applied a Class I label to the recall, warning that using ForeCYTE as a stand-in for mammography or other diagnostic procedures could put patients at serious risk. False positives could spur needless anxiety and unnecessary medical costs, the FDA said, while false negatives could lead to delayed diagnosis and treatment of breast cancer, increasing chances of death.

Atossa has said it's working with the FDA to get its banner product back on the market, but it may be difficult to reverse the damage, and the company's shares have fallen roughly 60% since October. The recall came amid Atossa's nationwide commercial scale-up for ForeCYTE, following partnerships with distribution giants McKesson and Thermo Fisher ($TMO) to spread the system around the country. The company believed its test had a chance to become as ubiquitous as the Pap smear, CEO Steven Quay said.

Atossa has said it hasn't heard of any adverse events tied to ForeCYTE, and the FDA is asking patients and physicians to report problems through its MedWatch platform.

Source: FDA

For more updates and trainings related to FDA, visit Compliance Trainings.

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Medical Devices and Pharmaceutical Quality Management System - Applying the Principles of Lean Documents and Lean Configuration

Scheduled On : Wednesday, November 20, 2013 at 10 AM PST | 1 PM EST

Duration : 60 Minutes

Description : 

The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach.  Lean documents presents a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.

Do you find yourself constantly struggling to create, manage, and maintain all of the information found in the documents of a typical QMS - which is often redundant, repetitive, and chained together in a cumbersome way?

Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on design, manufacturing, and supplier management?

This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.

Areas Covered in the Session :

• Brief introduction to Lean Documents and Lean Configuration
• Quality System Regulation, 21 CFR Part 820, ISO 13485, ICH Q10 Pharmaceutical Quality System
• Key elements of a Quality Management System (QMS)
• Applying lean principles to medical device QMS documents
• Applying lean principles to pharmaceutical QMS documents

Who Will Benefit: 

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

• R&D
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Quality Engineering
• Operations
• Document Control
• Lean Program Leaders

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Speaker Profile

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with ....more

Robust Corrective And Preventive Action (CAPA)

Scheduled On : Tuesday, November 12, 2013 at 10 AM PST | 1 PM EST
Duration : 90 Minutes

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Description : 

Vital elements of a robust, "bullet-proof", "closed-loop"  Corrective and Preventive Action (CAPA) program include: "Gatekeeper" capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis. Such a "closed-loop" CAPA system will meet / exceed CGMP requirements and U.S. FDA expectations. Robust CAPA requires a specific sequence of activities, each building on the other, to enhance patient safety and improve product quality.

It is also key to many other important cGMP activities -- Non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, other Verification and Validation activities, Audit corrective and preventive actions, et al. Simple tools and work flow are not understood, diseminated, and used, consistently.  Product failures, liability issues, scrap / waste / fall off, and needless recalls result, as evidenced in recent notorious events.

Avoid a "shoot from the hip" approach.  Define, then attack, and resolve root problems / causes, not just symptoms, using repeatable, systematic, SOP-defined methods as part of the "closed-loop" CAPA system.


A robust CAPA requires repeatable, systematic Failure Investigation and Root Cause Analysis. The FDA has faulted companies repeatedly for failure to identify, systematically investigate, resolve, and then verify/validate and monitor for reslution of the key underlying problem -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s) -- using a repeatable system.

The most important area audited by the FDA is CAPA -- it assures the FDA that company is in compliance without the Agency constantly auditing it. One of the most cited 483 observation is failure to resolve the key underlying problem and close out CAPA documents in a timely manner -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s). Regular, defined, systematic use of a few simple but powerful tools can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.

Areas Covered in the Session :

• Regulatory "Hot Buttons"
• CAPA Background
• Correction, Corrective Action, Preventive Action Defined
• Impact Analysis and Response - a Key Component
• CAPA System Assessment
• "Bullet-Proof"
• Data Sources / Metrics
• Monitor for Effectiveness
• "Closed-Loop" - Lock In the Change
• Beyond Regulatory Compliance

Who Will Benefit: 

This 90 minute in-depth webinar will provide valuable assistance to all regulated companies that need to review and modify their company's CAPA system.

Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:

• 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.

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.