Top 10 Problems And Solutions In Method Validation for Drug Development | March 27, 2012, 2-3 PM EST
This webinar will cover some of the most frequently observed issues and problems with method validations. Validated methods are required for Phase III of the drug development process. Moving methods from the development phase to the validated phase ready for sample analysis does not always occur without unforeseen issues arising. Differences in laboratories and analysts, as well as instrumentation can contribute to delays in validating methods.
Setting appropriate specifications and criteria based on solid data from development and qualification will help you have successful completion of method validations. Key issues may be overlooked or not anticipated when methods are developed, optimized, and qualified that can lead to assay failures during validation. Rushing to judgment can lead to unnecessary delays and repeated work. Setting solid requirements for determining that methods are ready for validation is critical. Unambiguous documentation of the method is also key when new analysts or laboratories are included in cross-validations. The attendees will understand key concepts from practical examples that will address major issues encountered during method validation.
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Things You Will Learn:
- Importance of defining the method and trending necessary information. Importance of setting appropriate specifications.
- Designing appropriate assays.
- Establishing correct specifications.
- Identifying an appropriate reference standard.
- Building on the foundation of a good qualification.
- Creating effective templates for validation studies.
Who Should Attend:
- Laboratory personnel responsible for day-to-day functioning of laboratories
- Laboratory managers monitoring critical systems and reportable results
- Scientific staff involved in assay development, qualification, and/or validation
About Your Speaker:
Dr. Wise-Blackman, is currently Principal Investigator, Immunochemistry, Covance Laboratories, Chantilly, VA. Dr. Wise-Blackman leads a matrix team that successfully develops, optimizes, validates, and performs PK, biomarker, and neutralizing antibody cell-based assays in a GLP environment. Previously, Dr. Wise-Blackman was Senior Manager, Cellular Technologies, at the Cardinal Health RTP-Bio site. for 9 years. Dr. Wise-Blackman lead a team that successfully developed, optimized, validated, and performed cell-based assays for lot release and stability projects in a GxP environment She was the co-recipient of both the Customer Focus Award for 3rd Quarter FY2004 and the Presidents Award for FY2004. Her expertise is GLP ELISA methods, GLP neutralizing antibody assays, and GMP bioassays to support release and stability testing of biotechnology products, Cell Based Screens, and Receptor Binding Assays. Dr. Wise-Blackman was previously employed at Dupont Pharmaceuticals for nine years, working in the cardiovascular pharmacology and high throughput screening departments. She received her Ph.D. in Pharmacology from the University of Virginia, Charlottesville, VA and her Bachelor of Science in Biology from the Massachusetts Institute of Technology, Cambridge, MA.
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Category : Upcoming Events
Compliant Safety Reporting in Clinical Trials – Are You Following FDA Rules? | March 7, 2012, 2-3 PM EST
This Safety Reporting in Clinical Trials webinar on March 7 will review FDA’s recent major revisions to IND safety reporting requirements. It will explain FDA’s current expectations of sponsors, investigators, IRBs, and other personnel responsible for reporting safety related information while conducting clinical trials with a new investigational product or a generic drug.
If your company or organization is involved in clinical trials, if you are a clinical site or safety monitoring/pharmacovigilance organization, if you with an IRB overseeing clinical trials, or if you are not sure of your compliance status with the current regulations, you can get valuable tips and training in less than an hour.
This Webinar will discuss the current requirements, differences from the older requirements, and tips to not only be compliant but processes to document how you address safety events in your clinical trials.
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Topics covered include:
- What has changed from earlier?
- How do these changes impact ongoing and recently completed clinical trials?
- Best practices to implement new safety reporting processes
- Do’s and Don’ts of safety reporting.
Learning Objectives:
Learn how to be compliant with current FDA requirements for safety reporting while maintaining high levels of patient confidence in your clinical trials and timely addressing adverse events.
More Topics in the Webinar:
- Current regulatory requirements.
- Rationale for these changes.
- Role of clinical investigators and sponsors.
- Amending existing SOPs and/or creating new ones.
- Training requirements for personnel.
- Good documentation practices for safety monitoring.
Learning objectives:
Learn how to be compliant with current FDA requirements for safety reporting while maintaining high levels of patient confidence in your clinical trials and timely addressing adverse events.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
- QA/QC/Compliance/Regulatory affairs professionals
- Clinical trial professionals (e.g., CRAs, coordinators, nurses, pharmacists)
- Investigators participating in clinical trials
- Sponsors and investigator-sponsors of clinical trials
- Pharmacovigilance professionals
- Clinical trial specialists
- Project Managers
- People investing in FDA-regulated product development projects
About the Speaker:
Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( www.amarexcro.com ). His key expertise is in regulatory affairs, clinical trials and multi-national 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.
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Category : Upcoming Events
Top Compliance Trends for 483 and Warning Letters for 2012 – Based on Rare FDA Data | March, 8, 2012, 2-3:30 PM EST | Moore
Note: This Webinar covers topics relevant to both drugs AND devices.
FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant.
Now, in our unique 90-minute webinar, you can learn the detailed trends of 483s and warning letters for 2012. Our speaker, Dennis Moore, Managing Partner, AUK Technical Services, is a 28 year veteran FDA investigator. Dennis recently had unlimited and highly unusual access to FDA 483 and warning letter trend data from 2010 and 2011. He has assembled a presentation that reveals a level of detail of FDA trend data that you cannot find anywhere else.
We have never seen this amount of detail in any FDA data on 483s and warning letters – ever. We also have never seen so much detail on data this fresh. Anyone who deals with FDA data regularly knows that most of their released data is 4 years old. This data is only a year old!
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A few things that you will learn in this 90 minute, detail-packed webinar:
- Top warning letter trends for 2012, such as more 806 enforcement
- The Top 10 QS 483 Observations for 2010 and 2011
- Most common quality system failures for drugs for 2010
- Top drug and device citations in 483s for 2010
- Top drug and device warning letter citations for 2010
- Total 2010 BIMO inspections for CDER, CBER, CDRH, and CVM
- Details on clinical investigator, sponsor/monitor and IRB audits for 2010
- Most common sponsor deficiencies for 2010
- The rising trend of ‘cease to market’ letters, one of which hit a NY pharma company in 2011
- The total number of 483s issued in 2010 and 2011 – an all time high
- Total CAPA 483 observations in 2010
- How long to receive a warning letter, based upon which offices issues it
- 483 inspection targets for drugs and devices for 2010, 2011, and 2012
- Total warning letters issued by drug and device category in 2010
- Which district offices write the most warning letters
- How long to receive a warning letter, based upon issuing office
- Warning letters issued by QS system for 2010
- 483s broken down by QS subsystem for 2010
- Warning letters by CFR section
- Top device 483 observations for 2010
- Details on process validation observations for 2010
- Design control 483 observations by category for 2010
It is very unusual to see this amount of detail in FDA data, especially data that is this recent. We have never seen it covered anywhere else. You will learn detailed, insider information on how FDA is thinking on 483s and warning letters. You can learn all kinds of details that can be a huge help to your firm when the next inspection rolls around.
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About Your Speaker:
Dennis M. Moore is currently Chief Technical Expert and Managing Partner of Auk Technical Services LTD, Beverly Hills, CA. Mr. Moore has 28 years of experience in medical device design, software design validation systems and evaluations, manufacturing software validation including ERP systems and FDA Predicate rules and the 21 CFR Part 11 rules as they apply to device firm’s quality systems. Mr. Moore also has experience training drug and device firms in all aspects of device and pharmaceutical manufacturing and 21 CFR 210,211 quality systems. Mr. Moore has extensive experience helping firms achieve compliance to FDA regulation and International Standards regulations. Recent achievements include CE marking a medical device, helping create a Combination Product Quality System; co-authoring a Technical File submission, and achieving ISO 13485:2003 and ISO 9001:2008 certification for a medical device manufacturer.
Additionally, Mr. Moore has extensive experience as a Level II FDA Investigator, California Medical Device and Drug Team Senior Investigator, Sworn Government-POST Certified Criminal Investigator, Lead Trainer, Compliance Officer and company Chief Technical Expert and CEO.
Mr. Moore has given numerous web seminars on GMP issues; has traveled the world putting out FDA compliance related fires and authored many documents on quality system inspection, FDA/CA narrative report compilation, drug quality systems and software auditing techniques.
Mr. Moore is a member of RAPS, AAMI and is a former official with the State of California Medical Device Team. Mr. Moore also has RAB certification to the ISO 13485:2003 standard. Mr. Moore holds a BA degree in Zoology, with Graduate work in Toxicology and a Sworn POST certified Government Criminal Investigator peace officer badge.
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Category : Upcoming Events
Audit Your Lab Like an FDA Auditor: A Roadmap to Lab Compliance – From cGMPs to Inspection Readiness| ARCHIVE| Medina
NOTE: This event occurred on Feb. 1, 2012, but is available for same-day download. We also can send you a CD by request.
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.
Carmen Medina was an FDA investigator based out of the Miami field office.
Regular Price: $399
Register Today! $50 Off!
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.
Regular Price: $399
Register Today! $50 Off!
Category : Upcoming Events
How to Manage Supplier Risk – Archived Presentation by John Avellanet
John Avellanet of Cerulean Associates LLC, presents a risk-based, cost-conscious approach to supplier selection, oversight and management. John is an an internationally acknowledged expert, speaker and syndicated author on lean regulatory compliance, preventing intellectual property theft and quality by design.
Order Now! Save 50% Off Regular Price ($349)
Same Day Download! CD Also Available at No Extra Cost!
Note: You can contact John by phone or email after the Webinar for your follow up questions.
Summary:
Under the new FDAAA of 2007, the US Congress authorized the FDA to fine individual executives $16,500 for each violation (e.g., 483 finding); this is in addition to multi-million dollar fines levied on the corporation as a whole. Given FDA’s stated intent to dramatically intensify supplier scrutiny and vendor oversight, selection and qualification of your vendors is absolutely crucial to both your quality program and your wallet.
This presentation reveals a successful roadmap to implement a component of lean compliance, effectively integrating risk management and cost-effectiveness as part of an approach to vendor selection and oversight. It will focus on how to design a strategy for lean supplier selection, effectively share the regulatory compliance risk, and ensure consistent vendor accountability.
Based on years of work with clients ranging from biopharmaceutical companies and start-up medical device firms, plus his own experiences as a device and biotech executive, Mr. Avellanet will show you how to improve your vendor management program to improve compliance, lower cost and minimize risk.
Components of the webinar will also discuss recent FDA expectations toward managing vendors, suppliers and contractors, and provide insights to achieve compliance.
What You Will Learn:
– Effective strategy for selecting suppliers
– Tactics to share the compliance burden and regulatory risk
– A systematic methodology to ensure vendor accountability
– The challenges in vendor management
– Different categories of suppliers
– What the FDA will be looking for when it comes to vendor management
– Organizational considerations in implementing a vendor management system
– The benefits of pursuing a lean supplier strategy
Order Now! Save $50 Off Regular Price ($349)
Same Day Download! CD Also Available at No Extra Cost!
About the Speaker:
Cerulean’s John Avellanet is an internationally renowned speaker, expert and authority on lean compliance practices and FDA cGMP, GLP, QSR, 21 CFR Part 11, ICH and GHTF.
He has trained FDA and Health Canada officials, spent over 15 years personally accountable for regulatory compliance, and has passed multiple regulatory inspections. He was personally trained by the authors of 21 CFR 11 to conduct FDA inspections himself. Mr. Avellanet has been called been called “the best in the business” by former FDA and Department of Justice officials.
Trusted by officials at FDA, NIH and the OIG, as well as by clients around the world, Mr. Avellanet provides practical, business-savvy solutions to strengthen compliance while lowering costs and reducing risk. He speaks frequently at industry conferences and organizations around the world.
Recent awards
Best of Business – Small Business Commerce Association
Top 10 FDA Compliance Blogs – FDAzilla Editors and Readers Choice
Top 50 Pharma / Biotech Blog – Biotechnology Graduate Students Association
Lifetime Achievement – Who’s Who of Pharmaceutical & Device Executives
He founded Cerulean in 2006, and today is an internationally acknowledged expert, speaker and syndicated author on lean FDA compliance .
Mr. Avellanet’s most recent book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, was featured at BIO 2011. He is a contributing author to the book Best Practices in Biotechnology Business Development, and publishes the monthly newsletter of quality systems tips and regulatory intelligence, SmarterCompliance.
Throughout his corporate career, Mr. Avellanet has been personally accountable for regulatory compliance and quality systems (including ICH, GHTF, FDA Parts 820 and 11), records management, and IT compliance.
Mr. Avellanet’s regulatory and quality expertise is based primarily on his experiences having to put in place, live under, and be audited upon various rules and regulations. He has since translated his mistakes and successes into client success stories – whether setting up flexible, risk-based GLP/GMP quality systems, putting in defensible document and record retention programs, conducting mock FDA audits, or helping companies recover from FDA inspections and warning letters.
Category : Upcoming Events
Dangerous Documents: How to Avoid Land Mines in Your FDA Documents and Emails | In-Person | Singer
Dangerous Documents: Avoiding Land Mines in Your Emails and Documents is a absolutely unique, in-person, all day event with former DOJ prosecutor Nancy Singer – where you will discover the potential consequences of writing emails and other documents that are inappropriate.
After this all day event, your employees will be motivated to create correspondence that, if subpoenaed, will demonstrate your firm’s commitment to quality and regulatory compliance… instead of exposing costly and embarrassing surprises. This interactive event can be presented to groups as small as 10 to 100 or more! In fact, Nancy greatly enjoys doing this event with very large groups, so bring your whole staff!
Interested in a one-on-one event at your site? Contact us now!
Or, call (703) 477-5941 today and leave a message. We’ll get right back to you.
Nancy will travel to your place of business and provide you with a deeply interactive, all day event, with team exercises tailored specifically for your company and team. She will review your firm’s SOPs and other important company documents that you provide. Then she will construct group exercises to show you where your documents go wrong, how they can get you in trouble with a prosecutor, and how to fix them!
“Dangerous Documents” has been presented to rave reviews at many major pharmaceutical firms, including:
- Medtronic
- Siemens
- Allergan
- Bayer
- Zimmer
Testimonials:
MEDTRONIC
“I learned techniques to address issues in a positive way, so they do not become bigger issues.”
- Gail Block, Project Manager
“This interactive course used good examples and made me more aware of the potential issues that can arise with documentation.”
- Catherine Perrone, Senior Regulatory Affairs Specialist
“I now will be more careful about how I will state things in my emails.”
- Sally Quest, Buy Planner
“I will write fewer emails and use more direct communication.”
- Al Beatrez, Commercial Release Manager
“I will not leave blanks in forms.”
- Stephanie Elhard, Senior Safety Manager
“I will rethink sending personal emails.”
- Teresa Peterson, Buyer Planner
“This course increased my awareness and I will take time to reread my emails before I push the send button.”
- Jan Dugas, Regulatory Trainer and Compliance Specialist
“I will look at what I write from an outsider’s perspective who is trying to tell a story.”
- Jenn Dolan, Technical Sourcing Specialist
SIEMENS
“I will pay more attention to non-project related documents.”
- Jim Wade, Systems Engineer
“I will use more precise and objective words.”
- Aiying Sun, Manager Quality System Validation
“I appreciated the exercises and the instructor’s ability to make people participate.” – Jorge Bohorquez, Applications Specialist
“I enjoyed the interaction as this provided a different way of looking at the same situation.”
- Ramin Nekouka, Senior Manager Technical Siemens
“I will be more mindful of my word selections in emails, text messages and other documentation.”
- Myrtis Randolph, Clinical Application Tester
ALLERGAN
“The course was very different than other training we have had. It was very informative and provided great information all compiled in one place.”
- Mirshshemi Sahba, QA/QC Director
“Very interactive and thought provoking.”
- Lisa Carroll, QA Manager
“Very pertinent to our work.”
- Teresa Kuan, Manager WWQA
“Pragmatic and animated.”
- Pasaf Chanton, Assistant Director European Quality
“Great group interaction.”
- Lilly Tu WWQA VP Biologics
“I wish it were longer.”
- Ava Yap, QA Manager
MASTERS DEGREE PROGRAM AT THE UNIVERSITY OF SOUTHERN CALIFORNIA
“This was very informative. It was lots of fun and an exciting way to learn.”
- Mahek Lamephriya, student in the MS program
“I now will think before writing and think before sending.”
- Yi Zhao, Research Assistant Professor, USC
“I will treat emails more formally.”
- Phyllis Tai, Post Doctoral Fellow, USC
“I now understand the importance of documenting and writing things correctly.”
- Rajas Chadanker, Post Doctoral Fellow, USC
“The program was lively, interactive and informative.”
- Michelle Chu, Quality Engineer
“I enjoyed the learning activities and I will use the communication and diplomatic skills.”
- Ankit Shah, MS, BME
COMPLIANCE SYMPOSIA AT HARVARD UNIVERSITY
“I enjoyed the examples provided, and hearing from the other participants.”
- Steven Klingerberg, Validation, Baxter Healthcare
“I appreciated the willingness to entertain attendees’ opinions during the course.”
- Steven Johnson, Vice President and Assistant General Counsel, Allergan
“It was helpful to learn about the interrelation of documentation and legal proceedings.”
- Garry Heidel, Director Regulatory Compliance, Alcon
“I appreciated the basic tips to improve my writing skills.”
- Snad Thele, Senior Manager Business Practices, Merck
“Great presentation; useful examples.”
- Henry Wroblewski, Regulatory Affairs, Bayer Health care
The course has also been delivered as part of the Masters program at the University of Southern California and at several compliance symposia at Harvard University. Participants’ reactions have been overwhelmingly positive. Engineers and software developers have said the course is so valuable that they wished it had continued longer.
Interested in a one-on-one event at your site? Contact us now!
Or, call (703) 477-5941 today and leave a message. We’ll get right back to you.
There are four components in the program:
1. Senior Management Overview (1-hour session)
This session provides a summary of the risks, examples where inappropriate documents have contributed to firms being found liable in products liability actions and the elements of the preventive action program.
2. Middle Management Leadership Education (2-hour session)
This section provides activities where managers learn to recognize the risks, reduce their individual exposure to these risks, and guide their direct reports on techniques to ensure that they write complete and accurate documents.
3. Company-Wide Hands-On Education (4-hour session)
This session provides actual in-depth practice. The participants are divided into groups. After hearing each stage of the instructional program, they analyze improperly written documents and revise them to reflect your firm’s commitment to quality. Specifically, participants:
* Rewrite a memo to assess their writing skills
* Make presentations to show how the firm employs risk management
* Discuss the do’s and don’ts for handling customer complaints
* Debate whether emails written on company computers should be audited
* Examine warning letters where the government has cited firms for poor documentation
* See how the former NY Attorney General used carelessly written documents
* Analyze a series of statements to determine which are facts and which are opinions
* Rewrite sentences that, when taken out of context, appear to be inflammatory
* Practice substituting less harsh words for inflammatory ones
* Read inappropriate emails from employees of Guidant, Merck, Bayer, Chevron, Arthur Andersen, and Microsoft that were reported in the media
4. Coordination and Customization Meetings (Up to 8 hours)
Compliance-Alliance can schedule an optional series of individual meetings with key department heads, and the senior compliance team, to ensure that we have a full understanding of the types of issues that might face the company.
Overview:
“Land mine” is a term we use for something buried in your company that will blow up if it is uncovered. In court, even an innocuous phrase in a private email from one of your employees, such as, “This will negatively impact the bottom line,” could be a land mine. In a products liability action, a plaintiff’s lawyer could use this statement to undermine the credibility of your organization.
When was the last time you cringed after reading an email sent by someone in your organization as you imagined how a prosecutor or plaintiff’s lawyer could use it to imply sinister behavior? Maybe it was just last week or last month. It’s not that your employees don’t care, it’s just that they don’t know.
Every day thousands of emails are sent by your server, which because of technology, can be retrieved indefinitely. As we say, Documents are like diamonds – they are very precious and they last forever.
To survive in our litigious society, organizations need to have the right communications culture. Everyone needs to understand what they should, or should not, write in their emails and other documents.
Industry leaders like Pfizer, Bayer, Chevron and Eli Lilly have learned the hard way when they were involved in costly lawsuits. Recently the media have reported that Wyeth’s reserve for Fen-Phen litigation is $21 billion and Merck’s exposure to Vioxx lawsuits may total as much as $50 billion. During discovery, these companies were forced to produce documents that contained embarrassing, inflammatory statements which contributed to their expensive settlements. In a particularly noteworthy case, Microsoft was subject to the same fate after it came to light that Bill Gates wrote in an email, “How much do we have to pay you to screw Netscape?”
All of your employees must know how to write emails and other documents that are complete and accurate and do not create land mines.
About the Presenter:
Nancy Singer founded Compliance-Alliance LLC to specialize in professional development for those employed in drug, device and other manufacturing industries. She created the course, “Dangerous Documents” when she was employed as General Counsel for a drug and device firm. While reviewing documents, she noticed that the employees at her firm failed to understand how a plaintiff’s lawyer could use their emails and other documents to the firm’s detriment if the firm was ever sued in a products liability action. She presented the course to her colleagues. The response was uniformly positive. She then took it to other firms, universities and industry meetings.
Singer’s career began as an attorney with the United States Department of Justice where, during a three year period, she successfully prosecuted seven firms for violations of various criminal statutes. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker. Singer received her B.S. from Cornell University, and J.D. and LL.M. degrees from New York University Law School. During her career she was an instructor at Catholic University Law School, George Washington University Law School, University of Southern California, and at compliance symposia at Harvard University. She received Vice President Gore’s Reinventing Government Hammer Award, the FDA Commissioner’s Special Citation, and the Food and Drug Law Institute’ s Distinguished Service and Leadership Award. Singer is a retired Commander in the United States Naval Reserve.
Interested in a one-on-one event at your site? Contact us now!
Or, call (703) 477-5941 today and leave a message. We’ll get right back to you.
Category : Upcoming Events
Vendor Qualification Auditing for FDA Computer System Compliance| Jan. 18, 2012 | Poser
Note: FOI Services ran this event this summer at $449, $100 more than our price. Theirs also was a regular audioconference. This is a Webinar!
This webinar by Dr. Richard Poser, First Quality, Inc., will explain and illustrate inspection and auditing of vendors who provide software used to support GXP manufacturing and testing, through audit forms, processes and checklists. We will explore how vendor qualification audits may be used in the vendor selection process. Case studies and redacted audit reports will be used throughout the presentation.
Note: All Expertbriefings.com Webinars are eligible for 1.0 CEU towards RACS Certification and 0.1 RU towards ASQ Certification.
Feedback from this event: “Dr. Poser, thank you for the wonderful training webinar this afternoon. I would greatly appreciate the documentation/templates that you described.”
“Greetings Dr. Poser, you put on an excellent presentation this afternoon with excellent suggestions and tools that can be applied. I am requesting the sample of documents you used today. Thank you.”
We will show how audit findings of competitive vendors may be used to select products and negotiate pricing and terms. We will examine the audit process from initial request to conduct an audit through the conduct of on site inspection, closing meetings and audit reports.
Illustrations of observations and remediation plans will be used throughout. The various types of audits will be discussed, including initial qualification, remediation, routine, for cause and correspondence. The seminar will include sample forms and checklists which may be used by the participants, along with some initial training on the appropriate use of forms and checklists.
Group Price: $349 ($50 Off Regular Price)
Recording Only (Download or CD): $299
Areas Covered in the seminar:
- Audit types.
- Pre-audit materials.
- Conducting site inspections.
- Closing meetings.
- Writing audit observations, recommendations and remediation.
- Use of audits in vendor qualification and selection.
Who will benefit:
This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and data systems will also benefit.
The employees who will benefit include:
- End-users responsible for testing
- QA managers and validation personnel
- Information systems managers and personnel
- Senior Quality, Facilities and R&D Management
- Regulatory Affairs staff
- Quality system auditors
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:
Rich Poser, is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the vendors such as contract laboratories, instrument manufacturers, contract manufacturing sites and software developers that support these highly regulated industries.
Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. Following work in product development, laboratory automation, and validation and quality systems for the Mylan Pharmaceutical Company, Rich joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. After the acquisition of Dura by Élan, Rich was appointed Director of Quality Laboratory Operations and led their 21CFR Part 11 training and audit team.
Now in private practice as a quality consultant, he also lectures at UCSD Extension in validation, cGMP Regulations and analytical methods validation, and has presented or chaired public seminars and symposia.
Group Price: $349 ($50 Off Regular Price)
Recording Only (Download or CD): $299
Category : Upcoming Events
Best Seller – How to Write FDA-Compliant Quality Agreements| Archive Recording|Minsk
In his 9th appearance in this highly praised webinar (see July 21 feedback below), discover a potential table of contents for your quality agreement, why you must use FDA defined terms where they exist. Learn the obligations for all stakeholders under a quality agreement, how to develop your quality agreement, and much much more.
Note that Alan has recently given this presentation to numerous interested FDA staff in Rockville, MD. It is a topic of great interest at FDA headquarters, so it should be for you as well!
Note: All Expertbriefings.com Webinars are eligible for 1.0 CEU towards RACS Certification and 0.1 RU towards ASQ Certification.
Feedback from July 21 Webinar:
“Thank you very much, this Webinar was very worthwhile.” Pfizer attendee
“I found yesterday’s conference call to be useful and interesting. The topic was especially timely for us, as we have recently started focusing attention on this.” Covidien attendee
“Very useful. Thank you!” Astrazeneca attendee
“I enjoyed your presentation yesterday and found it very useful as both Quality and Supplier Agreements have become a hot topic in the global marketplace. I realize your presentation was FDA based but I believe it will help build a strong foundation for other key markets. Well done!” Boston Scientific attendee.
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
Price: $349 ($50 Off Regular Price)
- 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: $349 ($50 Off Regular Price)
Category : Upcoming Events
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
