Discover Risk-Based Approaches for Qualifying SharePoint Enterprise Deployments and Validating SharePoint Composite Applications for FDA-Regulated Environments | Jan. 19, 2012, 2-3 PM EST | O’Driscoll/Youmans/Woergaard
This Webinar by a team of seasoned GXP validation and SharePoint experts will introduce innovative best practice risk-based strategies, important processes and new exciting tools to help qualify enterprise Microsoft SharePoint deployments as well as validate mission critical applications such as clinical and investigator portals and document management in FDA regulated environments.
The presentation — by speakers Gerry O’Driscoll, US Data Management, Chris Youmans, InnovoCommerce, Martin Woergaard, EpistaIT — begins with a high level introduction to SharePoint enterprise planning and deployment considerations for life science organizations that will consider use of validated applications.
Note: All Expertbriefings.com Webinars are eligible for 1.0 CEU towards RACS Certification and 0.1 RU towards ASQ Certification.
Price: $349 ($50 Off Regular Price)
What You Will Learn:
•Understand strategic validation choices for the enterprise SharePoint farm(s).
•Understand GAMP 5 risk-based approaches to qualifying the enterprise SharePoint deployment–key strategic and tactical considerations.
•Learn a risk-based matrix approach to understanding, identifying and attributing risk factors for enterprise SharePoint farm deployments, configuration management and compliance monitoring and change control.
•Learn essential change control and configuration management strategies and associated set of processes to properly manage a SharePoint farm.
•Discover how innovative new tools can be used to monitor and manage the qualified SharePoint environment – automated tools have been introduced to track changes to SharePoint environments
•Learn from real-case scenarios that evidence the mission-critical importance of leveraging risk-based approaches to qualifying and managing SharePoint enterprise environments— whether they are validated or not.
Price: $349 ($50 Off Regular Price)
About the Speakers:
Gerry O’Driscoll, Vice President, Practice Development of Enterprise Content Management, US Data Management
Gerry O’Driscoll has over 15 years experience in enterprise software and services delivery in the pharmaceuticals, biotechnology, and medical device industries. His experience within the regulated technology industries is extensive. Gerry has worked for industry leaders such as Phase Forward, ClinPhone (Perceptive Informatics) and Qumas. During his industry tenure he has received recognition for business development achievements and management results.
Chris Youmans, Vice President, Operations, InnovoCommerce
Chris Youmans is a seasoned professional with over 18 years of management, architecture, development and consulting experience. Chris has over 10 years’ experience in the high technology sector and over 8 years’ experience in the biotech and pharmaceutical industry. Chris is a veteran of the US Navy where he served as an Explosive Ordinance Disposal Combat Diver and has a BS in Information Systems from National University. Prior to joining InnovoCommerce, Chris worked for Biogen Idec, Day Software (Recently purchased by Adobe) and Ernst & Young.
Martin Woergaard, Co-Founder of epistaIT
Martin Woergaard is the co-founder of epista IT, an independent Life Science Consultancy dedicated to helping its clients find the perfect balance between risk and compliance. We have deep roots in the Life Science industry which give us a comprehensive understanding of its regulatory requirements. And unlike most other Life Science consultants, we also have advanced knowledge of the relevant technology. The result? Solutions that lower compliance costs and improve business processes.
Category : Upcoming Events
How to Avoid the Dreaded Refuse-to-File, Plus 2012 eCTD Mandate from Congress| Sept. 6, 2011, 2-3 PM EDT | Azevedo
One of our most praised presentations, this Webinar by renowned eCTD expert Antoinette Azevedo will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review. So you can avoid a costly Refuse-to-File (RTF) by FDA.
Note: All Expertbriefings.com Webinars are eligible for 1.0 CEU towards RACS Certification and 0.1 RU towards ASQ Certification.
6 Things You will Learn:
- Top issues regulatory authorities have with eCTD and how to avoid them.
- Preparing submission-ready source documents and datasets for submission in eCTD.
- Whether to purchase an eCTD publishing system or to outsource.
- The role of an electronic document management system (EDMS) in an eCTD publishing solution?
- How to prepare for the technical challenges of eCTD.
- How to interact with regulatory authorities to assure your eCTD submission is accepted for review.
Also, the presentation will provide details about the coming eCTD mandate from Congress:
Negotiations are underway between FDA and industry on PDUFA V reauthorization. These negotiations will result in legislation submitted to Congress in January 2012. PDUFA must be reauthorized by October 1, 2012 to enable CDER and CBER to collect user fees and perform review of INDs, DMFs, NDAs, ANDAs and BLAs. PDUFA V is expected to mandate eCTD format for all submissions to CDER and CBER except for single-patient compassionate-use INDs.
It is expected there will be a transition period from Oct. 1, 2012 to 2015 for certain submission types, but likely NDAs and BLAs will be required immediately, with a transition for DMFs and INDs.
It is also expected that CDISC standards for electronic datasets will be mandated.
Price: $349 ($50 Off Regular Price)
Recording Only Price: $299 (Download or CD)
- Attendees will receive these free gifts:
- Subscription to FDA Digest – 483/warning letter e-newsletter
- 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: $349 ($50 Off Regular Price)
Recording Only Price: $299 (Download or CD)
Category : Upcoming Events
Prepare Yourself for 21 CFR Part 11 Inspections| Jan. 24, 2012, 2-3 PM ET | Avellanet
FDA announced in 2011 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
Price: $349 (save $50!)
Testimonials:
“It was a pleasure listening to your webinar on 21 CFR Part 11 this week. I spoke with management and they are interested in your assistance with our SAP validation.”
“John Avellanet’s frequent speaking engagement requests from the industry are a reflection of his expertise and reputation. In 2009, we got to see this first hand. John helped us on a business-critical project expected to last 9 months. Midway through, senior management challenged us to expedite the project by 3 months and we succeeded thanks to John’s dedication to get the job done – and done right. If I had to characterize John and his firm Cerulean in 3 phrases, they’d be: expert, on-time and high integrity.”
Attendees will receive these free gifts:
- 3-month subscription to FDA Digest – 483/warning letter e-newsletter
- Complimentary recording of the event
- 3-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:
Price: $349 (save $50!)
Category : Upcoming Events
FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters | Jan. 10, 2012, 2-3 PM EDT| Bradshaw
This can easily happen to you if your company gets a serious warning letter. Or this:
Getting an FDA warning letter can cost you big. Terrible publicity. Big fines. Job loss. Consent decrees. Even jail time.
Join us and learn from former FDA Chief Council Sheldon Bradshaw. Learn about recent warning letters, including:
– Gilead Sciences
- Beckman Coulter
- H&P Industries (this one is a real nightmare)
Learn how to avoid the huge trouble that a warning letter can cause. Learn about FDA’s greater enforcement efforts and warning letter changes: setting post inspection deadlines, speeded up warning letter process, working more closely with regulatory partners, implementing warning letter close out process, and much more.
Note: All Expertbriefings.com Webinars are eligible for 1.0 CEU towards RACS Certification and 0.1 RU towards ASQ Certification.
PLUS, ask your warning letter questions to the former FDA Chief Counsel in a 15 minute Q/A session!
More:
- Set Post-Inspection Deadlines
- Speed Up Warning Letter Process
- Work More Closely with Regulatory Partners
- Prioritize Follow Up on Warning Letters
- Respond to Public Health Risks Immediately
- Implement Warning Letter Close Out Process
Also learn from Bradshaw:
- What is the new time frame in which companies must respond to a 483 before getting a warning letter?
- 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?
Regular Price $399 Now 50% Off!
- Attendees will receive these free gifts:
- Subscription to FDA Digest – 483/warning letter e-newsletter
- 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.
Regular Price $399 – Save $50!
Regular Price $399 Now 50% Off!
Category : Upcoming Events
Avoid FDA Enforcement: Configure and Validate Your Excel Spreadsheets to Prevent 483s| ARCHIVE | Nettleton
Learn how to configure and validate Excel applications to avoid 483s. This interactive webinar presents step-by-step instructions followed by a hands-on Excel workshop where each participant follows along with a live demonstration. You will become a better Excel user, saving you time and costs, while advancing compliance.
Archive Recording – Download Webinar the Same Day (CD also available at no extra cost)
Price: $349
NOTE: 45-minute Powerpoint Webinar is followed by a 30-minute, live step-by-step Excel workshop
Objectives:
- Develop spreadsheet applications that are GxP compliant.
- Learn how to use Excel’s built in 21 CFR Part 11 features.
- Apply features required for GxP environments without programming macros.
- Configure Excel for audit trails, security features, data verification, and multiple concurrent users.
- Avoid 483s and warning letters.
- Understand what does and does not need to be validated.
- Validate your application with minimal documentation.
Target Audience:
- All Excel users
- Laboratory staff
- QC
- QA
- IT
- Managers
- Executives
- Attendees will receive these free gifts:
- Subscription to FDA Digest – 483/warning letter e-newsletter
- 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 Speaker:
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 200 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is “Risk Based Software Validation – Ten easy Steps” (Davis Horwood International and PDA – www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.
Archive Recording – Download Webinar the Same Day (CD also available at no extra cost)
Price: $349
Category : Upcoming Events
FDA Expectations of Sr. Management| Archive Recording May 11, 2011| Avellanet
Learn how your senior management team can management FDA compliance effectively with just 48 hours per year. Discover 14 typical FDA auditor questions regarding quality systems management, top 7 FDA risk enforcement priorities. Learn six do’s and seven don’ts on effective quality management oversight.
Note: This is an archived recording of this highly popular Webinar from May 11, 2011. Order and download it today!
Price: Now $100 Off – Limited Time! – Was $349 (use offer code 59100, please)
What You Will Learn:
- How effective compliance senior management oversight takes just 48 HOURS PER YEAR
- The average cost per person (in thousands of dollars) for effective quality management oversight (less than this is an FDA red flag)
- 14 typical FDA auditor questions regarding your quality systems management
- Top 7 FDA risk enforcement priorities (5 involve your senior management team)
- The huge costs of a consent decree ($300 mil+ average) vs. effective quality management ($500k average)
- Huge costs of a post-warning letter clean up ($480k average) vs. mock FDA audit ($14K average)
- 6 do’s and 7 don’ts on effective quality management oversight
More:
- What the FDA expects of senior management when it comes to quality system and compliance infrastructure oversight
- Five crucial challenges to overcome to avoid FDA enforcement action
- How the inspector will determine if a quality system is being managed effectively
- What will prompt FDA to publicly name you … and how to avoid it
- Seven steps to take every year to prove effective oversight of SOPs and policies
- How to ethically limit your personal exposure as an officer of the company
You will receive ICH Q10 guidance with emphasis on management accountability, FDA warning letter samples that cite poor executive oversight, and OIG’s compliance program guidance for executives.
Attendees will receive these free gifts:
- Slides that you can print out and share
- 3-month subscription to FDA Digest – 483/warning letter e-newsletter
- Complimentary downloadable recording of the event
- 3-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 is an excellent speaker – one of the best I have ever heard. His message is direct, clear, timely, and relevant. His visuals enhance the message. He also includes many of his personal experiences that further support the discussion. Any organization or conference director would do well to make sure he’s prominent on the program.”
- Dr. Paul Pluta, Institute of Validation Technology, Chicago, Illinois
“Simply put, John is the best in the business. Period.”
- Nancy Singer, President of Compliance Alliance, Founder of AdvaMed’s Medical Technology Learning Institute (MTLI) and former FDA prosecutor, Washington, D.C.
“I challenge anyone to find a better speaker. You are passionate, enthusiastic, and dynamic. I heard nothing but praise from my colleagues. We were all impressed. Thank you.”
- Ginger Norfleet, San Francisco, California
“John is one of the best speakers I’ve ever heard in more than 20 years. John was clear, confident, and concise. He was able to simplify a complicated topic and make it interesting with real-life examples and personal stories.”
- Tom Golden, Director, Franklin, Tennessee
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: Now $100 Off – Limited Time! – Was $349
Category : Upcoming Events
How to Survive PREDICT – FDA’s New Import Screening Program | England | June 20, 2012, 2-3:30 PM EDT
REBOOKED due to popular demand: June 20, 2012
Feedback from our May 17 Webinar: “Thank you – the Webinar was extremely informative.” “Benjamin is a wonderful speaker and our team learned a lot today.” “Our staff really appreciated all of the great information the speaker related today.”
The FDA’s PREDICT system has DRASTICALLY changed how FDA screens your drugs and devices that arrive at US ports. And it is causing a great deal of confusion and questions in the pharmaceutical industry.
Background
For years, the FDA relied largely on entry document review and intuition in deciding which imports to detain for testing and scrutiny and which to let pass without review.
With PREDICT, this is all different. This new system is wonderful for companies that understand its intricacies and how to work the system to your best advantage.
Register Today – One registration covers your entire team!
But it is a headache for companies that are not familiar with PREDICT and try do business as they did before.
PREDICT lets FDA to take into consideration a whole array of new information to determine whether to examine a shipment – information that was not generally available to its inspectors before.
Now, when the agency reviews your drugs or medical devices, it will assess the following:
- The risks that are in the product, such as its potential harm to patients and how likely it is to be adulterated
- Past FDA audit results, both foreign and US, related to the product
- Sample analyses data and results from earlier product entries, and
- News and other accounts of problems with your products
So, under PREDICT, you must keep your company’s profile as clean as possible so you are not flagged in the new screening system. For companies with a clean record, PREDICT will result in faster import clearances.
But, if you don’t understand PREDICT, you won’t be able to take advantage of it. The best thing you can do to prevent big delays later on?
Register for an information-packed Webinar with the industry expert in drug/device importation: Benjamin England Esq.
Following a 17-year career as an FDA legal officer, Mr. England has helped drug and device manufacturers negotiate the release of dozens of FDA-regulated shipments into the U.S.
In this session you’ll learn how PREDICT works and how to institute best practices to improve supply chain and import procedures.
What You Will Learn
In this 90 minute session, England will cover it all so that you and your team are totally knowledgeable with PREDICT. Learn:
- History of PREDICT and current roll-out status
- Why voluntary data (i.e. Affirmations of Compliance) becomes more important
- Toughened enforcement of proper registration and listing data
- Assuring your PREDICT profile doesn’t raise red flags with the FDA
- How the PREDICT system will influence the import alert and hold process
- How the Food Safety Modernization Act may affect drugs and devices:
- Foreign Supplier Verification
- Mandatory Recall (drugs)
- Qualified Importer Program
- Foreign Inspection Targets
Register Today – One registration covers your entire team!
About the Speaker:
Benjamin L. England Esq. is founding member of Benjamin L. England & Associates LLC. During a 17-year FDA career, he served as Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. In private practice, he guides clients facing FDA and USDA inspection and enforcement actions, as well as FDA and Customs criminal investigations, inquiries and prosecutions; and helps clients leverage risk management programs for food, medical device or drug distribution against FDA and Customs import clearance processes.
• And much more
Register Today – One registration covers your entire team!
Category : Upcoming Events
Getting Ready for Tougher FDA GMP Inspections – Feb. 15, 2012, 2-3:30 PM EST
Recent FDA audits have shown us that the past ways of doing things will no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. Recent events in regulated industries indicate a public’s growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA.
How this is affecting the Agency’s approach to audits and their expectations for companies. Pressure on the 510(k) process is only one example. They also use GMP compliance audits to drive companies to do much of their work for them. How they drive companies to do much of their work for them. We will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate.
This new Webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA’s CGMP audit “paradigm”. Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.
Register Now!
Who Should Attend:
This webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA’s CGMP audit “paradigm”. Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance. This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceuticals and Biologics fields. The employees who will benefit include:
– Senior management
– Regulatory Affairs
– Quality Assurance
– Production
– Engineering
All personnel involved in a U.S. FDA-regulated environment. Especially those involved in the complaing handling, non-conforming material, out-of-specification, failure investigations, r oot cause analysis, labeling, distribution, storage, tracking, use or regulated medical products.
About the Speaker:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
Register Now!
Category : Upcoming Events
