Tougher Import Rules for FDA Imports in 2019

 

Course “Tougher Import Rules for FDA Imports in 2019” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Description:

FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA’s thinking, negotiate with the FDA and offer anecdotal examples of FDA’s import program curiosities.

Why you should attend:

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new “Automated Commercial Environment” computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port.

Who Will Benefit:

  • Domestic importers
  • Foreign exporter
  • Initial importers
  • International trade executives
  • Venture Capitalists
  • Marine insurance underwriters

Agenda:

Day 1 Schedule

Lecture 1:

FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation

Lecture 2:

FDA Import Process (continued)

  • Import Brokers
  • Prior Notice Information
  • CBP and FDA computer programs
  • Import Codes
  • Bonds and Bonded Warehouses
  • FDA “Notice of Action”

Lecture 3:

Import Delays Import Alerts Detention Refusals

Day 2 Schedule

Lecture 1:

Foreign Inspections FDA 483 – Inspectional Observations

Lecture 2:

FDA Warning Letters and Automatic detention

Lecture 3:

Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical

Lecture 4:

FDA Export Program Special Import Issues

  • Trade Shows
  • Personal Use
  • Compassionate Use

 

Speaker:

Casper Uldriks

ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed.

Location:  Washington, DC Date: April 4th & 5th, 2019 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON

 

Price:

1 ATTENDEE $2,000, Register for 1 attendee

5 ATTENDEES $10,000, Register for 5 attendees

10 ATTENDEES $20,000, Register for 10 attendees

Until March 10, Early Bird Price: $2,000.00
From March 11 to April 02, Regular Price: $2,200.00

 

Sponsorship Program benefits for seminar

For More Information– 

 

 

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

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Seminar on Biostatistics for the Non-Statistician

Why should you attend:

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?

This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

The focus of the seminar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.

Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.


Who will benefit:

  • Physicians
  • Clinical Research Associates
  • Clinical Project Managers/Leaders
  • Sponsors
  • Regulatory Professionals who use statistical concepts/terminology in reporting
  • Medical Writers who need to interpret statistical reports

Day 1 Schedule


Lecture 1 (90 Mins):

Why Statistics?

  • Do we really need statistical tests?
  • Sample vs. Population
  • Statistician ≠ Magician. What statistics can and can’t do.
  • Descriptive statistics & measures of variability.

Lecture 2 (90 Mins):

The many ways of interpretation

  • P-values
  • Effect sizes
  • Confidence intervals
  • Statistical vs. Meaningful significance

Lecture 3 (90 Mins):

Common Statistical Tests

  • Why Test? Null Hypothesis Significance Testing (NHST)
  • Comparative tests
  • Correlation
  • Multiple Regression analysis
  • Non-parametric techniques

Lecture 4 (90 Mins):

Bayesian Logic

  • A different way of thinking
  • Bayesian methods and statistical significance
  • Bayesian applications to diagnostics testing
  • Bayesian applications to genetics

Day 2 Schedule


Lecture 1 (90 Mins):

Interpreting Statistics – Team Exercise

  • Team Exercise: Review a scientific paper and learn how to
  • Interpret statistical jargon
  • Look for reproducibility, transparency, bias, and limitations
  • Convey information coherently to non-statisticians

Lecture 2 (90 Mins):

Study power and sample size

  • Review of p-value, significance level, effect size and how they are use in sample size calculations
  • Formulas, software, and other resources for computing a sample size.

Lecture 3 (90 Mins):

Developing a Statistical Analysis Plan

  • Using FDA guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP).
  • An SAP template will be given to all attendees.

Lecture 4 (90 Mins):

Specialized topics/Closing Comments/Q&A

  • Logistic Regression.
  • Comparing survival curves
  • Cox Regression
  • Question and answer session.

Speaker

Elaine Eisenbeisz

Owner and Principal Statistician, Omega Statistics

Elaine Eisenbeisz, is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.

In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.

Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics with a minor in Quantitative Management, Accounting. Elaine received her Master’s Certification in Applied Statistcs from Texas A&M, and is currently finishing her graduate studies at Rochester Institute of Technology. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.

Elaine has designed the methodology for numerous studies in the clinical, biotech, and health care fields. She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutriceutical and fitness studies with QPS, a CRO based in Delaware. Elaine has also worked as a contract statistician with numerous private researchers and biotech start-ups as well as with larger companies such as Allergan and Rio Tinto Minerals. Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at http://www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.

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How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud

Course “How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
  • Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
  • The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
  • Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
  • This seminar will help you understand the specific requirements associated with local and SaaS/cloud hosting solutions.
  • Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated.
  • Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
  • Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
  • This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Course Objectives:

  • Understand what is expected in 21 CFR Part 11 and Annex 11 inspections
  • Avoid 483 and Warning Letters
  • Learn how to buy COTS software and qualify vendors.
  • Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
  • Requirements for local, SaaS, and cloud hosting
  • How to select resources and manage validation projects
  • “Right size” change control methods that allows quick and safe system evolution
  • Minimize the validation documentation to reduce costs without increasing regulatory or business risk
  • Write test cases that trace to elements of risk management
  • Protect intellectual property and keep electronic records safe

    Day 1 Schedule


    Day 1 (8am to 5pm; 0.5 registration, 1.0 lunch, 0.5 (2-15min) breaks, 7.0 class = 9.0)
    8:00am to 8:30am registration
    8:30am class starts


    Lecture 1:
    Introduction to the FDA (1:30) {1:30}

    • How the regulations help your company to be successful
    • Which data and systems are subject to Part 11

    Lecture 2:
    21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures (4:00) {5:30}

    • What Part 11 means to you, not just what it says in the regulations
    • Avoid 483 and Warning Letters
    • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
    • How SaaS/cloud computing changes qualification and validation
    • Ensure data integrity, security, and protect intellectual property
    • Understand the current computer system industry standards for security, data transfer, and audit trails
    • Electronic signatures, digital pens, 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

    Lecture 3:
    The Five Keys to COTS Computer System Validation (0:30) {6:30}

    • The Who, What, Where, When, and Why of CSV

    Lecture 4:
    The Validation Team (0:30) {7:00}

    • How to select team members
    • How to facilitate a validation project

    Day 2 Schedule


    Day 2 (9am to 3:30pm; 1.0 lunch, 0.5 (2-15min) breaks, 5.00 class = 6.5)


    Lecture 5:
    Ten-Step Process for COTS Risk-Based Computer System Validation (1:00) {1:00}

    • Learn which documents the FDA expects to audit.
    • How to use the risk-based validation approach to lower costs.
    • How to link requirements, specifications, risk management, and testing.
    • Document a computer system validation project using easy to understand fill-in-the-blank templates.
    • Based on: “Risk-Based Software Validation – Ten Easy Steps” (Davis Horwood International and PDA – http://www.pda.org, 2006).

    Lecture 6:
    How to Write Requirements and Specifications (0:30) {1:30}

    • Workshop for writing requirements and then expanding them for specifications

    Lecture 7:
    How to Conduct a Hazard Analysis/Risk Assessment-Exercise (0:30) {2:00}

    • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

    Lecture 8:
    Software Testing (1:00) {3:00}

    • Reduce testing by writing test cases that trace to elements of risk management.
    • How to write efficient test cases

    Lecture 9:
    System Change Control (0:30) {3:30}

    • How to manage a validated system with minimal documentation

    Lecture 10:
    Purchasing COTS Software (0:30) {4:00}

    • How to purchase COTS software and evaluate software vendors.

    Lecture 11:
    Cost Reduction Without Increasing Regulatory or Business Risk (1:00) {5:00}

    • How to save money
    • How to increase quality
    • How to increase compliance with less documentation

      Carolyn Troiano

      Consultant, BrainStorm Central Consulting

      Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

      During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

     

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Best Biostatistics Tips You Will Read This Year

How do you know if you are pressing the right key, let alone performing the best test?

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?

biostatistics

This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

The focus of the seminar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.

Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.

  • Physicians
  • Clinical Research Associates
  • Clinical Project Managers/Leaders
  • Sponsors
  • Regulatory Professionals who use statistical concepts/terminology in reporting
  • Medical Writers who need to interpret statistical reports

A guide to practical Risk Management [ISO14971 and IEC62304]

Risk management being a mandatory component of almost any activity in the medical device industry.

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.

management

To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

Risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.

The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.

The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner’s perspective.

Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Project managers
  • Design engineers
  • Software engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Medical affairs
  • Legal Professionals

How to interpret and use more than just a standard tool-box

Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications.

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

  • ISO standards and FDA/MDD regulations regarding the use of statistics.
  • Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
  • Statistical Process Control
  • Statistical methods for Design Verification
  • Statistical methods for Product/Process Qualification
  • Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications
  • How to craft “statistically valid conclusion statements” (e.g., for reports)
  • Summary recommendations

The various statistical methods used to support such activities can be intimidating. If used incorrectly or inappropriately, statistical methods can result in new products being launched that should have been kept in R&D; or, conversely, new products not being launched that, if analyzed correctly, would have met all requirements. In QC, mistakenly chosen sample sizes and inappropriate statistical methods may result in purchased product being rejected that should have passed, and vice-versa.

This provides a practical approach to understanding how to interpret and use more than just a standard tool-box of statistical methods; topics include: Confidence intervals, t-tests, Normal K-tables, Normality tests, Confidence/reliability calculations, Reliability plotting (for extremely non-normal data), AQL sampling plans, Metrology (i.e., statistical analysis of measurement uncertainty ), and Statistical Process Control. Without a clear understanding and correct implementation of such methods, a company risks not only significantly increasing its complaint rates, scrap rates, and time-to-market, but also risks significantly reducing its product and service quality, its customer satisfaction levels, and its profit margins.

  • FDA, ISO 9001/13485, and MDD requirements related to statistical methods
  • How to apply statistical methods to manage product-related risks to patient, doctor, and the designing/manufacturing company
  • Design Control processes (verification, validation, risk management, design input)
  • QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment)
  • Manufacturing processes (process validation, equipment qualification)

product-development-process-e1395175968927

  • QA/QC Supervisor
  • Process Engineer
  • Manufacturing Engineer
  • QC/QC Technician
  • Manufacturing Technician
  • R&D Engineer

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How the Things Will Change The Way You Approach [Phase I Gmps]

Including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

manufacturing

So, that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.

  • Directors
  • Managers
  • Supervisors in Regulatory Affairs
  • Manufacturing
  • Quality Assurance, and Clinical Operations