In the next FDA Digest
5 Deadly Sins in GLP Warning Letters
Upcoming Expertbriefing Webinar
AVELLANET
Oct. 12, 2010, 2-3 PM EDT
How to Prepare Yourself for Coming 21 CFR Part 11 Inspections
Speaker: John Avellanet, Managing Director, Cerulean Associates LLC
“I would go out of my way to hear John speak on any subject just to enjoy his style of message delivery. He speaks with a brilliant combination of energy, humor, positive attitude, and solid meat-on-the-bones details. Just perfect.” – Pharmaceutical CEO comment from 2009.
FDA announced July 8 that it will soon begin to conduct 21 CFR Part 11 inspections. Are you ready? In this Webinar, John Avellanet will detail how to prepare yourself for coming Part 11 audits by FDA, as well as how to comply with the revised EMA Annex 11.
What You Will Learn:
- Status of Part 11 and Annex 11
- New requirements
- Major differences between the new interpretations and the old versions
- Risk-based validation justification details
- Leveraging vendor efforts, documentation and services
- The challenges in managing electronic records
- Recent FDA warning letters related to computer systems and e-records
- What inspectors will look for around IT compliance and electronic records
- Recommendations for compliance implementation
Attendees will receive these free gifts:
- Subscription to FDA Digest – 483/warning letter e-newsletter
- Complimentary recording of the event
- FDA Risk Evaluation and Mitigation Strategies (REMS) guidance white paper by Alan Minsk (Oct 2009)
- Six-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
- Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
- “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)
About the Presenter
John Avellanet, author of Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (Logos Press), is the founder and managing director of Cerulean Associates LLC. His clients include Fortune 50 biopharmaceutical firms, medical device startups, and everything in between.
Mr. Avellanet has gained tremendous acclaim for his speeches, workshops, and business-savvy compliance consulting work with corporate clients and conference venues around the world. One CEO recently commented,
“I would go out of my way to hear John speak on any subject just to enjoy his style of message delivery. He speaks with a brilliant combination of energy, humor, positive attitude, and solid meat-on-the-bones details. Just perfect.”
You can learn more about Mr. Avellanet through his independent advisory firm, Cerulean Associates LLC, on the web at http://www.Ceruleanllc.com, or through his award-winning blog at http://www.ComplianceZen.com.
Price:
Live GotoMeeting Webinar: $399
Audio/Video Recording (download. CD by request): $349
Upcoming Expertbriefing Webinar
AZEVEDO
Sept. 15, 2-3 PM EDT
Best Strategies for the Organization of Clinical Datasets in eCTD Submissions
Speaker: eCTD expert Antoinette Azevedo, President e-Submissionssolutions.com
One of our most highly rated Webinars!
“Thanks for organizing the Webinar on May 20th on the organization of clinical datasets in eCTD submissions. We enjoyed and benefited from the telecon a lot.”
Ms. Azevedo will explain in detail all of the do’s and don’ts of electronic datasets, including:
- What are the requirements for electronic datasets in eCTD submissions?
- Where are the contents of clinical datasets located in the eCTD structure for: tabulation datasets, analysis-ready datasets and programs, and patient profiles?
- What approaches should be taken to assure submission-readiness of datasets?
- How can the datasets package be remediated for submission if the deliverables are not submission-ready?
- What is the impact of CDISC and what steps should be taken now to assure compliance with CDISC requirements?
- What steps should be taken if electronic datasets are not available?
Overview:
Electronic datasets have been required with New Drug Applications (NDA) and Biologic License Applications (BLA) since 1999. The guidance documents that describe the organzation of electronic datasets in electronic submissions have been withdrawn. Since January 1, 2008, US FDA has required electronic submissions in the eCTD format, which changes the location of electronic datasets. This presentation will review the documentation requirements, the electronic navigation aids required for all the components of the electronic datasets package for a clinical study. Emphasis will be placed on best practices for assuring the datasets package is received in submission-ready format from internal and external biostatisticians. It will also discuss the impact of CDISC on the future of electronic datasets.
Attendees will receive these free gifts:
- Subscription to FDA Digest – 483/warning letter e-newsletter
- Complimentary recording of the event
- FDA Risk Evaluation and Mitigation Strategies (REMS) guidance white paper by Alan Minsk (Oct 2009)
- Six-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
- Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
- “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)
About the Presenter
Antoinette Azevedo founded e-SubmissionsSolutions.com (a California corporation) to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Ms. Azevedo’s clients range from large, international pharmaceutical companies to small, virtual biotechnology companies — all attempting to be better prepared to manage controlled documents and produce electronic INDs and drug/biologic registrations.
Price:
Live GotoMeeting Webinar: $399
Audio/Video Recording (download. CD by request): $349
Upcoming Expertbriefing Webinar
O’CONNOR
Sept. 14, 2-3 PM EDT
Risk-Based Approaches for Validating Enterprise SharePoint Deployment in FDA-Regulated Environments
Speaker: Daniel O’Connor, Co-Founder, InnovoCommerce LLC
This Webinar by Daniel O’Connor, Co-Founder, InnovoCommerce LLC, will introduce innovative best practice risk-based approaches to validating enterprise Microsoft SharePoint deployments in FDA regulated environments.
What You Will Learn:
- Learn how you can deploy a risk-based approach to validating the
enterprise SharePoint deployment - Understand key steps that any company must take to establish a risk based strategy to SharePoint enterprise validation
- Better understand some potential pitfalls not widely understood about SharePoint enterprise deployments when considering validated web applications.
- See work product examples including risk matrix, validation document check lists, templates and high level task, duration and resource
requirements for an enterprise SharePoint validation project
Details:
The presentation begins with a high level introduction to SharePoint enterprise planning and deployment considerations for life science organizations that will consider use of validated applications. Thereafter the presentation helps the attendee understand strategic validation choices for the enterprise SharePoint farm(s).
The presenters then include an overview of GAMP 5 risk-based approaches to validating the enterprise SharePoint deployment–key strategic and tactical considerations are introduced. The presenters then introduce the risk-based matrix approach to understanding, identifying and attributing risk factors for enterprise SharePoint validation execution and ongoing control.
After providing a summary of the mission-critical risk matrix, the presenters provide sample views of how to understand, identify and review risk in a SharePoint enterprise environment.
Thereafter real case scenarios are introduced and addressed that demonstrate the mission-critical importance of leveraging risk-based approaches to managing SharePoint enterprise environments— whether they are validate or not. Finally the presenters introduce an overview of SharePoint enterprise validation execution tool kit including the documents and plan templates that any life science organization should consider to ensure that their enterprise SharePoint deployments are correctly qualified and managed to ensure compliance.
Attendees will receive these free gifts:
- Subscription to FDA Digest – 483/warning letter e-newsletter
- Complimentary recording of the event
- FDA Risk Evaluation and Mitigation Strategies (REMS) guidance white paper by Alan Minsk (Oct 2009)
- Six-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
- Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
- “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)
About the Presenter
Daniel O’Connor brings extensive expertise and real world SharePoint business adoption experience to this webinar. For the past decade, Daniel has been involved with the evolution of enterprise document management solutions and Microsoft-based productivity tools adopted in regulated industry. As VP of Business Development for Workshare, a leading Microsoft-based document collaboration and change management software provider, Daniel spearheaded document management partner and integration arrangements with companies such as Documentum, Open Text, Qumas and MasterControl. Daniel’s team was involved with evaluating the very first SharePoint release as a document management platform candidate.
Price:
Live GotoMeeting Webinar: $399
Audio/Video Recording (download. CD by request): $349
Upcoming Expertbriefing Webinar
PERKINS
Sept. 21, 2-3 PM EDT
How to Prepare for FDA Audits of Clinical Studies (and the Top 5 Things Auditors Hate)
Speaker: Jeri Perkins, M.D., former FDA medical officer, President, Perkins & Perkins, Inc.
Former FDA medical officer Jeri Perkins, M.D., will show you exactly how to take the anxiety out of federal inspection of clinical trials, as well as the top 5 things FDA auditors don’t like, and, the top reasons for clinical citations.
You also will learn the the top reasons in recent years for clinical deficiencies, plus top reasons for deficiences in for-cause inspections.
Dr. Perkins also will discuss the auditing procedure by the Center for Devices (CDRH), and what are the most common deficiencies.
Details:
As you know, CROs and clinical research personnel are often intimidated by the prospect of an FDA audit. There is much mystique surrounding the FDA audit process. This interactive session will relieve your anxieties by explaining how you can prepare for FDA. Let this former FDA medical officer reveal what to expect during an FDA inspection by describing what the FDA is actually looking for at your site and why these inspections are crucial to drug/device approval process.
Attendees will receive these free gifts:
- Subscription to FDA Digest – 483/warning letter e-newsletter,
- Complimentary recording of the event
- FDA Risk Evaluation and Mitigation Strategies (REMS) guidance white paper by Alan Minsk (Oct 2009)
- Six-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
- Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
- “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)
About the Presenter
Dr. Perkins spent eight years at FDA as a medical officer. She was an Acting Division Director for medical devices, involved in policy decisions in the Office of the Commissioner and a Reviewing Medical Officer for drugs. She made recommendations to the FDA Commissioner on whether or not unsafe products should be recalled from the market. She also made recommendations whether or not devices and drugs were safe and effective for the US market.
In 1984, she established Perkins & Perkins, Inc, PPI, a medical and regulatory consulting firm. PPI is an independent consulting firm, assisting both pharmaceutical and medical device industries with regulatory and clinical trials quality assurance (GCP). Dr. Perkins has conducted pre-FDA audit inspections in the U.S. and Europe. Her audit reports have been used successfully to prepare sites for FDA inspections.
She has published basic research articles while at the NIH and articles regarding FDA issues. She has given numerous presentations in the USA, Europe and was an invited speaker in China.
She has published articles on HOW DOES A MEDICAL OFFICER REVIEW AN NDA SUBMISSION AND TIPS ON PMA PREPARATION/PRESENTATION.
Dr. Perkins did her post-doctoral research at the National Institutes of Health in Bethesda, MD and received her MD degree from the Medical College of Virginia.
Price:
Live GotoMeeting Webinar: $399
Audio/Video Recording (download. CD by request): $349
Upcoming Expertbriefing Webinar
MINSK
Sept, 16, 2010, 2-3 PM EDT
How to Write FDA-Compliant Quality Agreements
Speaker: Alan G. Minsk, Partner and Chair, Food and Drug Practice Team, ArnallGolden Gregory LLP
In an encore presentation of our top-selling Webinar of all time, Alan explains the do’s and don’ts of writing quality agreements, with a focus on both drugs and medical devices.
What You Will Learn:
- Why it is critical to have a quality agreement — FDA may ask during an audit to review docs that describe how you manage contract service providers
- Potential table of contents for a quality agreement
- Why you must use FDA defined terms where they exist – FDA’s terminology must be considered sacred
- Obligations for all stakeholders under a quality agreement — applicantion holder has ultimate responsibility for GMP compliance
- How to develop a quality agreement — quality departments of sponsor AND vendor must be involved, flexibility is key, how to work with vendor’s QA
- Relationship between the supply and quality agreement
- The relationship between a commercial and quality agreement — can be one document but quality section should be extractable
- How to work with vendors to develop a quality agreement — conducting due diligence is critical
- Why you need to have a contract with your suppliers on quality
Attendees will receive these free gifts:
- Subscription to FDA Digest – 483/warning letter e-newsletter,
- Complimentary recording of the event
- FDA Risk Evaluation and Mitigation Strategies (REMS) guidance white paper by Alan Minsk (Oct 2009)
- Six-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
- Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
- “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)
About the Presenter
Alan Minsk is a Partner and Practice Leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP. Mr. Minsk advises pharmaceutical, medical device and food companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration and the Drug Enforcement Administration.
For companies in the pre-approval phase, Mr. Minsk counsels on clinical trial issues, imports and exports, regulatory strategy including 505(b)(2) new drug applications, orphan drugs, combination products, market exclusivity, premarket notifications, premarket approval applications, communications with FDA, and pre-approval discussions. He also drafts and reviews agreements relating to clinical trials, quality, and contract manufacturing. For companies in the commercial phase, he advises on lifecycle management, post-market surveillance, Citizen Petitions, FDA enforcement and inspections, fraud and abuse compliance, promotion and advertising, product liability and interactions with FDA. In addition, works with life science companies and venture capital firms on regulatory diligence matters involving acquisitions, divestitures, co-promotions and licensing. Mr. Minsk conducts in-house training on a wide variety of FDA and fraud and abuse-related topics.
He is the General Counsel and a Board member of the PDMA Alliance, Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability.
Price:
Live GotoMeeting Webinar: $399
Audio/Video Recording (download. CD by request): $349
Upcoming Expertbriefing Webinar
BRADSHAW
Oct. 21, 2-3 PM EDT
Former FDA Chief Counsel Advises on Critical Warning Letter Changes
Speaker: Sheldon Bradshaw, Partner, Hunton & Williams LLP, Former FDA Chief Counsel
- What is the new time frame in which companies must respond?
- How to respond to warning letters and untitled letters?
- Will FDA send you a warning letter before taking action?
- What are the criteria for FDA taking enforcement action WITHOUT sending a letter first?
- How to avoid and recover from a warning letter? What proactive plans should be in place to avoid warning letters?
- How quickly can the Office of Chief Counsel take you to court after a warning letter is issued.
- The difference between warning and untitled letters;
- The significance of receiving a warning letter;
- How to avoid and recover from a warning letter;
- The role of the Office of Chief Counsel (OCC) in reviewing warning letters;
- GAO’s May 2008 congressional testimony on warning letters.
Attendees will receive these free gifts:
- Subscription to FDA Digest – 483/warning letter e-newsletter
- Complimentary recording of the event
- FDA Risk Evaluation and Mitigation Strategies (REMS) guidance white paper by Alan Minsk (Oct 2009)
- Six-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
- Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
- “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)
About the Presenter
In October 2007, Sheldon Bradshaw joined Hunton & Williams LLP as a partner and co-chair of the firm’s Food and Drug Practice Group. Mr. Bradshaw came to the firm from the U.S. Food and Drug Administration (FDA), where he served as Chief Counsel. As Chief Counsel, Mr. Bradshaw was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA’s senior leadership – including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers – on issues related to drugs, biologics, medical devices, food, animal feed and drugs, cosmetics, dietary supplements and other products regulated under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act.
In addition, he oversaw all FDA-related litigation and reviewed and approved every significant regulation and guidance document promulgated by the FDA and every significant warning letter issued by the FDA. Prior to his service at the FDA, Mr. Bradshaw held several senior positions at the U.S. Department of Justice where he, among other things, provided advice to FDA and testified before Congress on matters under the FDA’s jurisdiction. At the firm, Mr. Bradshaw advises clients in the same areas in which he worked while Chief Counsel of FDA.
Price:
Live GotoMeeting Webinar: $399
Audio/Video Recording (download. CD by request): $349
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