Upcoming Events


AVELLANET

Date Added After Sold-Out March Webinar! – May 11, 2011, 2-3 PM EDT

Effective Quality Systems Compliance – FDA Expectations of Sr. Management

Speaker: Renowned Compliance Speaker John Avellanet, Managing Director, Cerulean Associates LLC, Author of Highly Praised FDA Blog ComplianceZen

Register Online Now
SALE – Save $199.50 w/Offer Code 1012199 Today Only!

Feedback on Past Events:

“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

Webinar Summary:

FDA is increasingly citing companies and naming executives for failure to ensure an effective quality system, failure to ensure SOPs are being followed, and failure to enforce policies and procedures. Under FDAAA 2007, the agency has the power to levy civil penalties on individual executives and withhold approval of new drugs and devices.

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, 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 (Save $199.50 With Offer Code 1012199)

Register Online Now


NEW EVENT – Upcoming Expertbriefing Webinar


AVELLANET

May 18, 2011, 2-3 PM EDT

How to Help Your CMO or CRO Pass an FDA Inspection

Speaker: John Avellanet, Managing Director, Cerulean Associates LLC

Price: $399.00

Register Online Now

How good are Avellanet’s Webinars? So good that Webinar registrants become his clients:

“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.”

FDA is increasingly holding both sponsors and contract organizations responsible for a product’s safety and effectiveness. Whether in clinical trials or in the post-market stage, patient safety is the #1 driver for FDA enforcement. So how do you ensure your CMO or CRO can pass an inspection centered around your product? And will the agency only inspect the contracted manufacturer or trial monitor … or are there reasons why the inspector will visit you first?
Join supplier compliance expert, John Avellanet, as he walks attendees through the FDA’s evolving approach to enforcing product safety and efficacy when it comes to CMOs and CROs. Learn how to strike a defensible balance between supplier oversight and contracted outsourcing. Get expert experience and advice on protecting yourself – and your contract partners – from regulatory enforcement, financial loss, and litigation.

Over the past 16 years, Mr. Avellanet has become a leading international expert on FDA regulatory compliance and taking advantage of cutting-edge techniques to bring new products to market and achieve cost-effective compliance. In his career, Mr. Avellanet has learned hard lessons on how to evaluate and manage critical suppliers – and how to avoid hidden pitfalls. His acclaimed book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, has been repeatedly praised for its business-savvy advice and practical tips, giving readers a productivity advantage in today’s economy.
Now, exclusive to Expert Briefings, Mr. Avellanet, brings a review of the FDA’s latest strategy for ensuring product safety through contracted suppliers. Join us on May __ for a practical run through of how to stay on top of this evolving enforcement trend.

What you’ll learn:

• Reasons why the FDA is now looking at both the contractor and sponsor
• What the agency looks for when inspecting both the CMO/CRO and the sponsor
• A three-point lean compliance strategy for you and your CMO/CRO
• How to prepare your CMO/CRO for an inspection of your product
• How to support your CMO/CRO during the inspection
• How to help the CMO/CRO respond to the inspection
• An eight-step lean compliance critical supplier audit strategy

This webinar will give you a set of tried and true 21st century techniques to improve compliance, maximize productivity, and lower risk.

What you’ll receive:
• A detailed list of the SOPs, forms and policies you’ll need
• List of FDA, ICH and GHTF guidance documents to rely upon
• An example supplier questionnaire
• (insert the usual stuff from Expert Briefings)
• Four risk-free trial issues of the FDA regulatory intelligence newsletter, SmarterCompliance

Who should attend:
• Regulatory affairs professionals
• Quality management executives
• Supplier management and procurement professionals
• Chemistry and manufacturing controls directors
• Clinical trial planners and managers
• Compliance and records management professionals
• Supplier audit teams
• Anyone interested in using regulatory intelligence to ensure compliance currency

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:

Live GotoMeeting Webinar: $399.00

Register Online Now


NEW DATE – Upcoming Expertbriefing Webinar


AVELLANET

Date TBD, 2011, 2-3 PM EDT

How to Prepare Yourself for Coming 21 CFR Part 11 Inspections

Speaker: John Avellanet, Managing Director, Cerulean Associates LLC

Price: $399.00

Register Online Now

How good are Avellanet’s Webinars? So good that Webinar registrants become his clients:

“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.”

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:

  • 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:

Live GotoMeeting Webinar: $399.00

Register Online Now


Upcoming Expertbriefing Webinar


MEDINA

May 19, 2011, 2-4 PM EDT

Safeguarding Clinical Trial Activities: Prepare for GCP BIMO Inspections

Speaker: Carmen Medina, MPH, Ph.D., President, Precision Consultants, (PCI) Inc.

Carmen Medina was an FDA investigator based out of the Miami field office.

Price: $399.00

Register Online Now

With clinical trials on the rise and international trials outnumbering US trials 10 to 1, concerns within FDA’s Office of Scientific Investigation are mounting. The majority of BIMO inspections result in the issuance of an FD-483 delineating serious deficiencies, or in a clinical hold.

In an effort to develop well-trained clinical investigators, this exclusive webinar provides a comprehensive overview related to new legislation and regulations, subject safety concerns, the myths associated with adverse event monitoring, compliance with both the legal and ethical clinical trial obligations, ensuring adequate and acceptable scientific data, and most importantly—how to prepare for the BIMO inspection and mitigate the most common pitfalls.

Taught by a former FDA investigator, this unprecedented 2-hour webinar covers all aspects of clinical trial activities, everything from basic concepts of clinical trial design, fraud detection and CI compliance, to what the FDA expects of CRO’s, foreign data and clinical trial material. Join us in assessing several high profile cases in order to fully understand current regulatory and compliance trends.

Part 1:

  • FDA Expectations of Clinical Trials and Investigators
  • CRO’s and their QA Responsibilities
  • New Regulations and Legislative Changes
  • Ensuring High Quality Data
  • Subject Safety
  • Evaluating Site Performance
  • CTM Considerations

Part 2:

  • A BIMO Focus (How to audit like an FDA Investigator)
  • Fraud Detection
  • Foreign Studies
  • Auditing Adverse Events
  • Clinical Investigator Financial Disclosure
  • Charging for Investigational Drugs
  • Review of Regulatory Trends: Ripped from the Headlines

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

Carmen Medina oversees PCI’s consulting services for the West Coast BIO region and internationally from her San Diego office. She was a former Commissioned Officer in the United States Public Health Service and an FDA investigator, where she led an international group within Team Biologics and helped usher in the new medical device regulations—QSR. Ms. Medina, a graduate of the Columbia University School of Administrative Medicine and School of Public Health, is internationally renowned for her work with the biotech, pharmaceutical and medical device industries.

Over the past 20 years, she has assisted with the development, successful approval, and commercialization of hundreds of products, including some of the largest pharmaceutical and biotech brands. She has also consulted with several vaccine manufacturing companies throughout the world, including The Salk Institute Biotechnology/Industrial Associates. Ms. Medina has helped numerous pharmaceutical, medical device and biologics firms with FDA inspection-readiness and specializes in risk management, compliance, quality assurance and regulatory strategy. Her unique approach to PAI-readiness has garnered PCI extensive accolades from both domestic and international companies for its support in the commercialization of medically needed products. She is editor of the textbook, The Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics, as well as numerous articles related to reimbursement, innovative approval pathways, and exit strategies for start-up and emerging biotech companies.

Price:

Live GotoMeeting Webinar: $399.00

Register Online Now


Upcoming Expertbriefing Webinar


MEDINA

DATE TBD, 2011, 2-3 PM EST

FDA Investigator Perspective: Getting the Most from QSR Built In Risk Management

Speaker: Carmen Medina, MPH, Ph.D., President, Precision Consultants, (PCI) Inc.

Carmen Medina was an FDA  investigator based out of the Miami field office.

Price: $399.00

Register Online Now

FDA’s current expectations related to risk assessment and management make understanding how to optimize the QSR imperative for domestic and foreign device firms. Understanding how to converge an effective risk management program with proper implementation of the Quality Systems Regulations nearly guarantees a device firm sustainable quality and durable compliance. In this new Webinar learn to:

  • Identify the myriad of risk management tools offered by the QSR
  • Learn how to integrate these tools to create a far-reaching and comprehensive and quality and risk management program
  • Understand how to interpret and apply the spirit of specific QSR regulations from the design phase though commercialization
  • Gain insight into how these systems working in tandem will significantly reduce risk within any medical device firm—regardless of its size.
  • Optimize implementation of QSR
  • Learn how to get the most out of what was invested in your firm’s QSR infrastructure

Background:

The QSR were brilliantly conceived in that they provide inherent mechanisms aimed at, quality assurance, risk management and crisis prevention. Codified nearly a decade ago, the new medical device regulations go along way in imparting to those firms who choose to comply, a remarkably integrated and comprehensive infrastructure for risk assessment, preemption and management. Crisis prevention, management and recovery within the device industry are made that much easier because of the design of these forward-thinking regulations—providing, of course, that they are properly interpreted and implemented. Failure in the implementation of QSR, not in their potential is usually at the heart of a device firm’s failure to achieve durable compliance and minimize risk.

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

Carmen Medina oversees PCI’s consulting services for the West Coast BIO region and internationally from her San Diego office. She was a former Commissioned Officer in the United States Public Health Service and an FDA investigator, where she led an international group within Team Biologics and helped usher in the new medical device regulations—QSR. Ms. Medina, a graduate of the Columbia University School of Administrative Medicine and School of Public Health, is internationally renowned for her work with the biotech, pharmaceutical and medical device industries.

Over the past 20 years, she has assisted with the development, successful approval, and commercialization of hundreds of products, including some of the largest pharmaceutical and biotech brands. She has also consulted with several vaccine manufacturing companies throughout the world, including The Salk Institute Biotechnology/Industrial Associates. Ms. Medina has helped numerous pharmaceutical, medical device and biologics firms with FDA inspection-readiness and specializes in risk management, compliance, quality assurance and regulatory strategy. Her unique approach to PAI-readiness has garnered PCI extensive accolades from both domestic and international companies for its support in the commercialization of medically needed products. She is editor of the textbook, The Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics, as well as numerous articles related to reimbursement, innovative approval pathways, and exit strategies for start-up and emerging biotech companies.

Price:

Live GotoMeeting Webinar: $399.00

Register Online Now


Upcoming Expertbriefing Webinar


MEDINA

May 10, 2011, 2-4 PM EDT

Audit Your Lab Like an FDA Auditor: A Roadmap to Lab Compliance – From cGMPs to Inspection Readiness

NEW DATE – Back After Packed 3/2 Webinar!

Speaker: Carmen Medina, MPH, Ph.D., President, Precision Consultants, (PCI) Inc.

Carmen Medina was an FDA investigator based out of the Miami field office.

Price: $399.00 – 50% Off w/Offer Code 1012199

Register Online Now

This one-of a kind, comprehensive workshop will guide participants through understanding the substantive requirements for any lab, domestic or foreign, interested in validating, testing, and releasing drug product in support of regulatory submissions, as clinical trial material, or for commercial US distribution.

Taken straight from the pages of the IOM: Investigator Operator Manual, you will discover tips and strategies to avoid your lab being dinged by FDA in these crucial areas:

• Written, formalized SOPs, test procedures, protocols and specs for QC
• Adequate personnel training on GMPs and applicable SOPs
• Personnel qualifications
• Facilities:, instruments, glassware, workspace, and storage
• Instrument calibration and qualification
• Chemical reagents and reference standards: laboratory controls
• Test methods: validation of non-compendial methods
• Analytical methods: assessment of validation
• Sample tracking: Control of components and drug products
• Date recording: lab test results, control and documentation
• OOS results: lab data control
• Test result review
• Reserve samples: appropriate maintenance of active raw materials
• Stability testing program
• Complaint program: documentation, investigation and follow-up
• Computerized systems: validation of computer hardware/software
• Changes to formal documentation
• Inventory of raw materials and components
• Sampling plans for incoming materials and components
• Rejected materials
• R&D equipment

A former FDA official will discuss the regulatory requirements and industry standards associated with everything from validation of compendial procedures and analytical methods, cleaning validation standards, and development SOPs to advanced lab auditing techniques, stability program design, outsourcing and development of laboratory personnel training programs.

Participants will explore current laboratory compliance trends, learn how to employ a risk-based approach to managing a cGMP laboratory, enhance their understanding of OOS/OOT investigations, and finally discover what it means to truly be inspection-ready.

FDA’s current emphasis on risk management, critical path and QbD makes it imperative for US and foreign laboratories, regardless of their size, to fully understand the changes currently underway. This comprehensive workshop will explore:

I. FDA’s Latest Thinking and Expectations
• Integrate Risk-management during the entire life-cycle of a product: Concept to Commerce
• How to Identify and Mitigate Your Lab’s Specific Compliance Challenges

II. ICH and FDA Guidelines and Initiatives
• Discover the synchronicity between current ICH, and FDA Quality Initiatives
• Learn requirements for foreign and domestic labs—redefining their regulatory, USP, and compliance approach.
• Apply QbD, and Critical Path Initiatives where possible

III. Principles of Methods Validation Master Plan
• Examine regulatory requirements for analytical method, compendial validation: the nuts & bolts of method validation
• Optimize current OOS and OOT Investigation Procedures

IV. Integrating Risk Management into Stability Testing Program
• Learn to design a compliant Stability Testing Program.
• Optimize COT and LIM Systems support for Stability Studies
• Outsourcing

V. Recall Prevention as an intrinsic component of Laboratory Quality Management
• Develop select criteria for recall prevention
• Model an “Alert & Response” System for managing laboratory risk
• Install forward-quality Lab Personnel Training Programs

VI. Laboratory Inspection Readiness: Soup to Nuts
• Manage the Contract Lab
• Audit like an FDA Investigator
• Ensure Data Authenticity & Integrity
• Understand Methods Transfer Requirements
• Essential Laboratory Controls & Oversight

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

Carmen Medina oversees PCI’s consulting services for the West Coast BIO region and internationally from her San Diego office. She was a former Commissioned Officer in the United States Public Health Service and an FDA investigator, where she led an international group within Team Biologics and helped usher in the new medical device regulations—QSR. Ms. Medina, a graduate of the Columbia University School of Administrative Medicine and School of Public Health, is internationally renowned for her work with the biotech, pharmaceutical and medical device industries.

Over the past 20 years, she has assisted with the development, successful approval, and commercialization of hundreds of products, including some of the largest pharmaceutical and biotech brands. She has also consulted with several vaccine manufacturing companies throughout the world, including The Salk Institute Biotechnology/Industrial Associates. Ms. Medina has helped numerous pharmaceutical, medical device and biologics firms with FDA inspection-readiness and specializes in risk management, compliance, quality assurance and regulatory strategy. Her unique approach to PAI-readiness has garnered PCI extensive accolades from both domestic and international companies for its support in the commercialization of medically needed products. She is editor of the textbook, The Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics, as well as numerous articles related to reimbursement, innovative approval pathways, and exit strategies for start-up and emerging biotech companies.

Price:

Live GotoMeeting Webinar: $399.00

Register Online Now


Upcoming Expertbriefing Webinar


NETTLETON

June 20, 2011, 2-3:30 PM EST

Avoid FDA Enforcement: Configure and Validate Your Excel Spreadsheets to Prevent 483s

Speaker: David Nettleton, Computer System Validation, FDA Compliance Expert

Price: $399.00

Register Online Now

NOTE: 45-minute Powerpoint Webinar is followed by a 30-minute, live step-by-step Excel workshop

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.
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 Presenter
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.

Price:

Live GotoMeeting Webinar: $399.00

Register Online Now


Upcoming Expertbriefing Full Day Webinar


NETTLETON

April 19, 2011, 10 AM – 5 PM EST

How to Reduce Costs When Performing Computer System Validation, Comply with 21 CFR Part 11, and Cut Software Implementation Time and Costs by 33%

Speaker: David Nettleton, Computer System Validation, FDA Compliance Expert

Price: Register Single Person: $599.00; Register Group: $999.00

NOTE: This is a 7 hour workshop that, pending approval, will earn you 6 RAPS RAC credits for live attendance

This interactive one-day virtual seminar provides proven techniques for reducing costs associated with implementing, using and maintaining computer systems in regulated environments. Nearly every computerized system utilized in laboratory, clinical, manufacturing and the quality process has to be validated.

Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This often results in a savings of two-thirds the costs. Additionally, this course will help companies increase compliance with the new 21 CFR Part 11 regulations and demonstrate how to use risk management to improve system performance and promote process improvement.

How It Works: The webinar has a series of modules, each about 60 minutes long. Our speaker, Mr. David Nettleton, will deliver the modules using PowerPoint slides. At the end of each module, there is an interactive portion where participants can ask questions and clarify information. The modules also include multiple-choice questions to help participants assure they understand the material. Some of the modules contain exercises for participants that help illustrate the points covered and further increase learning. The interactive portion includes a discussion of the questions and exercises.

Full Day Outline:

1. Introduction to the FDA (60 Min)

Interactive discussion that builds the foundation for electronic records:

* Why the FDA regulates.
* How the regulations work together.
* Introduction to Part 11.
* Predicate rules.
* FDA and international standards.
* GAMP.

2. 21 CFR Part 11 – Compliance for Electronic Records and Signatures (120 Min)

Interactive discussion that details the regulation and how it applies to computerized systems. What makes this session unique is the understanding of how the concepts of Part 11 affect industry standards related to computer systems.

* Which data and systems are subject to Part 11.
* What Part 11 means, not just what it says.
* Avoid 483 and warning letters.
* Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
* Ensure data integrity and protect intellectual property.
* Current computer system industry standards for security, data transfer, and audit trails.
* Digital pens, electronic signatures, and biometric signatures.
* SOPs required for the IT infrastructure.
* Product features to look for when purchasing COTS software.
* Reduce validation resources by using easy to understand fill-in-the-blank validation documents.

3. The Five Keys to COTS Computer System Validation (30 Min)

Interactive discussion of the fundamentals of user validation for Commercial Off-The-Shelf (COTS) software as required by 21 CFR Part 11. What makes this session unique is the complexity of the topic is restated in terms everyone can understand.

* Apply the Who, What, Where, When, and Why of risk-based computer system validation.
* Understand the real life common errors and how to avoid them.
* Reduce staff resources, documentation, and project timelines.
* Real life examples to ensure success.
* Recommendations for performing efficient validation projects.
* How to use resources effectively.
* Increase compliance while lowering costs.

4. Selecting a Validation Team That Is Effective (30 Min)

Interactive discussion that describes how to assemble a validation team for maximum productivity and most efficient use of resources.

* Members.
* Team characteristics.
* How to facilitate and how to lead.
* How to get the right people to work together so validation is efficient and takes only one-third the time.

5. How to Write Requirements and Specifications (30 Min)

Workshop exercises that teach how to write a requirement and then build upon it to write a specification. What makes this session unique is the hands on experience of authoring as a team.

* How requirements and specification differ.
* What they have in common.
* How to author as a team.
* Workshop exercises.

6. Software Testing – How to Reduce Time and Costs (30 Min)

Interactive discussion that details the role of testing within the risk-based validation approach in order to reduce time and costs while ensuring process controls.

* Testing concepts and tools for efficient testing.
* Static vs. dynamic test methods.
* How to perform and document testing.
* How to track bugs and issues during testing.
* How to use testing to verify system acceptance without testing everything.
* Proven techniques for reducing testing time and documentation while improving defect detection.
* How to efficiently write and execute test cases.
* How to develop the testing protocol.
* How to reduce testing to one-third the time.
* It concludes with an array of testing strategies that improve quality and reduce testing time.

7. Cost Reduction Without Increasing Regulatory or Business Risk (60 Min)

Interactive discussion that summarizes the proven techniques that reduce validation project time, often to one-third. What makes this session unique is the compilation of proven techniques that are not obvious until understood in the context of the work being performed. It is especially good for managementand 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 Presenter
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.

Price:

Register Single Person Now – $599.00

Register Group Now – $999.00


Upcoming Expertbriefing Webinar


BRADSHAW

May 19, 2011, 2-3 PM EDT

Warning Letter Update from Former FDA Chief Council Sheldon Bradshaw

Speaker: Sheldon Bradshaw, Hunton & Williams LLP, partner and co-chair of the firm’s Food and Drug Practice Group

Price: $399.00 (50% Off w/Offer Code 1012199)

Register Online Now

FDA is committed to more aggressive enforcement, in the words of Commissioner Hamburg to be ‘more aggressive and forward leaning.’

Join us and learn from former FDA Chief Council Sheldon Bradshaw about FDA’s greater enforcement efforts and warning letter changes:

  • 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?
    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.

Price:

Live GotoMeeting Webinar: $399.00 (50% Off w/Offer Code 1012199)

Register Online Now


Upcoming Expertbriefing Webinar


MINSK

May 12, 2011, 2-3 PM EDT

Best Seller – How to Write FDA-Compliant Quality Agreements

Speaker: Alan Minsk, Partner and Chair, Food and Drug Practice Team, Arnall Golden Gregory LLP

Price: $399.00 (50% Off w/Offer Code 1012199)

Register Online Now

Our top-selling Webinar of all time! In his 8th appearance in this highly praised webinar, 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
  • 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, he 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: $399.00 (50% Off w/Offer Code 1012199)

Register Online Now

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