9 Vital Courses on FDA Regulation: 21 CFR Part-11, 510(k), Excel Spreadsheet Validation, GMP Guidelines, Compliance and Custom's Requirements

This comprehensive training package will discuss the regulatory perspective on promoting off-label uses for manufacturers, essential elements of a TMF for clinical trials, activities of set-up, maintenance, and monitoring will be discussed using case studies to highlight common deficiencies and potential solutions. Package highlights key elements of rules governing HCT/Ps using case studies, learn the methods to plan and execute Excel Spreadsheet Validations that satisfy FDA Requirements and know more about FDA guidance on Mobile Medical Apps., uses. This training is intended to discuss the recent changes, hurdles, and requirements for premarket notification [510(k)] compliant with eCopy and Refuse to Accept Policy (RTA) requirements, learn how to develop a standard approach to testing for all computer system efforts regulated by FDA that will be robust and will meet all compliance requirements, get guidelines and practical insights on 21 CFR Part 11 namely Electronic Records and Electronic Signatures and also know the best practices to implement these in a regulated environment.
Instructor: Mukesh Kumar , David Amor , Dr. David Lim , Carolyn Troiano
Product ID: PACK70055

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies, Dietary supplement manufacturers
  • Marketing and Advertising Professionals
  • Financial analysts and investors, venture capitalists, insurance professionals
  • Legal experts involved in advising manufacturers of marketed products
  • Senior management for companies developing new products for US market
  • Regulatory affairs professionals, research analysts
  • Clinical Research Associates (CRAs)
  • Clinical Research Coordinators (CRCs)
  • Clinical Research Administrators
  • Data Managers
  • Principal Investigators
  • Project Managers
  • Sponsors of INDs
  • Quality Assurance
  • Quality Control
  • Managers and owners of HCT/P marketing companies
  • Regulatory and quality professionals working in HCT/P manufacturing sites
  • Hospital and clinics using HCT/Ps
  • System owners and personnel who create or use spreadsheets in FDA regulated areas
  • IT / IS managers and personnel
  • Validation specialists
  • Software quality reviewers
  • Complaint and risk management personnel
  • Clinical affairs (associates, specialists, managers, directors or VPs)
  • U.S. importers of FDA regulated products
  • Foreign exporters of FDA regulated products (companies which sell regulated products to U.S. importers)
  • Logistics/Supply chain managers and analysts
  • Trade regulatory/legislative affairs professionals
  • Customs or Trade Compliance Personnel or Officers
  • Customs Brokers

Webinars included in the Package:

Off-Label Uses of Medical Products Under FDA Rules: Walking the Fine Line of Promotion Verses Scientific Discussion (Duration: 90 Minutes)

Recently the US courts have made some high-profile decisions regarding FDA’s punitive actions to manufacturers accused of off-label promotion. One case, the Caronia case, has been in much discussion since in that case the court sided with the defendant accused of off-label promotion leading to speculation of its impact on FDA’s enforcement of its rules regarding off-label promotion. The legal discussion apart, these cases have raised new regulatory questions about FDA-acceptable practices for promoting off-label uses for approved products. This webinar will discuss the regulatory impact of recent court decisions and strategies for introducing new uses for approved products.

Objectives of the Presentation:

  • Current FDA accepted definition of off-label, in-label, published and anecdotal information
  • FDA guidance documents about off-label promotion
  • Review of case-studies from unsuccessful and successful promotion of off-label uses
  • Practical tips for training of sales and marketing teams in off-label uses of products
  • Regulatory strategies for converting off-label uses to in-label uses

Instructor Profile:

Mukesh Kumar is an experienced auditor and a trainer in regulatory and business processes. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets.

FDA Rules for Trial Master Files (Duration: 90 Minutes)

The first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF). The TMF is a collection of the essential documents to record a site has fulfilled its obligations to the sponsor regarding a clinical trial project. Common deficiencies identified by FDA auditors during review of TMFs will be discussed with potential solutions to the same. Also discussed will be issues related to the kind of products being tested, responsibilities of individuals, resources available, and projected trends for the near future.

Objectives of the Presentation:

  • FDA's expectation from site and sponsor's documents
  • Required components of a TMF
  • Best practices for the set-up and maintenance of TMF
  • Electronic and Paper TMF requirements
  • Common errors in TMF management

Instructor Profile:

Mukesh Kumar is an experienced auditor and a trainer in regulatory and business processes. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets.

FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (Duration: 90 Minutes)

If you involved in HCT/Ps, you should be aware of the increased scrutiny from FDA regarding manufacturers in terms of increased audits, Untitled Letters, and product recalls. This webinar will provide a summary of the existing rules, the common complaints from FDA, ways in which companies have tried to comply and practical tips for assuring ongoing compliance status using case studies.

Objectives of the Presentation:

  • Current regulations for HCT/Ps and review of 21CFR 1271
  • GMP and GTP for HCT/Ps
  • Procedures for registration and listing
  • Common FDA audit findings for HCT/P manufacturing sites
  • Best practices for addressing audit findings and negotiations with FDA

Instructor Profile:

Mukesh Kumar is an experienced auditor and a trainer in regulatory and business processes. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets.

Using Excel Spreadsheets in FDA Regulated Environment (Duration: 90 Minutes)

Capability to use Excel creates an inexpensive and handy tool for FDA regulated industry, particularly R&D operations and early stage development activities. However, companies frequently struggle with understanding and implementing applicable regulations on spreadsheets. Many companies use invalidated spreadsheets leading to negative audit findings. This webinar will address all these issues by providing methods for planning and executing spreadsheet validations that satisfy FDA requirements.

Objectives of the Presentation:

  • Regulatory requirements for spreadsheets
  • Spreadsheet design considerations and validation methods
  • Risk based evaluation and qualification of spreadsheets
  • Documentation requirements
  • Common FDA audit findings and solutions

Instructor Profile:

Mukesh Kumar is an experienced auditor and a trainer in regulatory and business processes. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets.

FDA Guidance on Mobile Medical Apps (Duration: 60 Minutes)

The FDA's recent guidance on mobile medical apps addresses different regulatory requirements for categories of apps and coupled equipment. This course will provide a practical overview of mobile medical app regulations including examples of devices and companies that have gone through the process. Review differences between mobile medical apps regulated by FDA discretion/ un-regulated. Explore regulatory filing strategies with case studies and innovative approaches to mobile health products. The FDA supports the progress of mobile medical apps that betters healthcare and supplies consumers and healthcare professionals with precious health information. The FDA also has a public health responsibility to manage the safety and efficacy of medical devices - including mobile medical apps.

Objectives of the Presentation:

  • Mobile medical app regulations
  • Filing strategies and examples

Instructor Profile:

David Amor is a medical device consultant, having worked with companies such as Boston Scientific, St. Jude Medical and Hospira in helping develop quality management systems and product development infrastructures. A graduate of the Senior Innovation Fellows program at the University of Minnesota Medical Device Center, David was named a Top 40 Under 40 Medical Device Innovator in 2012 and founded MEDgineering, a niche quality consulting firm focusing on FDA remediation and remote work solutions (www.medgineering.com).

Understanding FDAs Recent 510(k) Guidance and New Requirements (Duration: 60 Minutes)

This webinar will provide ample opportunities to streamline your 510(k) preparation and submission in a way to adequately meet both eCopy and RTA policy and save a significant amount of time, energy, and resources. It is important to ensure you are familiar with the latest FDA guidance so that you can demonstrate substantial equivalence of your device to a predicate(s) pursuant to the statutory requirements as set out in the FDA guidance document.

Objectives of the Presentation:

  • Laws and regulations
  • Definitions
  • FDA's recent guidance document
  • New 510(k) requirements
  • Refuse to accept (RTA) policy
  • eCopy program
  • Who/when it is required to submit a 510(k)
  • Regulatory requirements: performance testing
  • 510(k) content and format
  • How to increase 510(k) submission quality for a product
  • How to respond to FDA's request of additional information
  • How to resolve different opinions between the submitter and FDA reviewer(s)
  • Common mistakes
  • Best practices: PASS-IT solutions

Instructor Profile:

Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner. Over the years, Dr. Lim has analyzed thousands of FDA warning letters including thousands of MDRs. Dr. Lim has also attended more than 50 FDA advisory panel Meetings and analyzed the subject matters and decision-making processes.

In-Depth Testing for Computer Systems Regulated by FDA (Duration: 60 Minutes)

The attendee will learn how to develop a standard approach to testing for all computer system efforts regulated by FDA that will be robust and will meet all compliance requirements. There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the practices that delivers the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available to assure a compliant testing process.

Objectives of the Presentation:

The course will focus on the key aspects of testing, including best practices and principles for a computer system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution of the product, or during any other functional activity). The material will include the various components of testing, including planning, execution, documentation and preparing a summary report. The result will be a prescriptive approach to conducting testing of any computer system regulated by FDA.

FDA guidelines are very specific in terms of how computer systems are to be tested, and each company should have a specific strategy and methodology, along with a set of rigorous internal policies and procedures that prescribe how testing should be planned, executed and documented.

Instructor Profile:

Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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.

21 CFR Part 11 Electronic Records/Electronic Signature and FDA-Regulated Computer Systems (Duration: 60 Minutes)

This course is intended to provide specific guidelines for coaching attendees in the concepts of 21 CFR Part 11, namely the FDA requirements for using electronic records and electronic signatures (ER/ES), and the best practices for implementing these technologies in a FDA regulated environment. There are specific best practices that should be considered before choosing to implement these capabilities and operate in a "paperless" environment. We will discuss the pros and cons for using ER/ES, and talk about the ramifications of choosing to do so. The attendee will be prepared to make a determination about applying ER/ES capabilities in their workplace, and will be able to implement the best practices for maintaining ER/ES in a compliant manner.

Objectives of the Presentation:

The course will focus on the use of ER/ES in the FDA-regulated marketplace, which may be of interest in a drive to reduce costs and improve compliance. While ER/ES use can be beneficial, there are some caveats that will be discussed in detail through examples.

We will present best practices and principles for establishing and maintaining computer system compliance while using ER/ES capability in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution of the product, or during any other functional activity). The result will be a prescriptive approach to helping teams and individuals reach a higher level of compliance.

FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how everyday work, along with the challenges and risks should be managed.

Instructor Profile:

Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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.

Import of FDA Regulated Products into the US: FDA and Custom's Requirements at the Port of Entry (Duration: 60 Minutes)

This webinar is intended for importers of FDA regulated products or those that sell regulated products to the U.S. importers and wish to have a better understanding of how FDA regulated products are entered into the U.S. Attendees will be introduced to the customs entry process, customs bond requirements for regulated products; HTS classification of regulated products; FDA import product codes; FDA affirmation of compliance numbers and the FDA entry. Attending this training will help you to better manage your import compliance activities and help support your logistics supply chain.

Objectives of the Presentation:

The objectives of the presentation are to cover areas such as:
  • FDA entry review process
  • US Customs import documentation requirements
  • US Customs bond requirements
  • HTS classification of regulated products
  • FDA import product codes
  • FDA import affirmation of compliance codes
  • FDA Prior Notice
  • FDA ITACS system
  • Role of US import agent
  • Dealing with refusal to entry or delay in entry hold

Instructor Profile:

Mukesh Kumar is an experienced auditor and a trainer in regulatory and business processes. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets.

Price:$2000.00
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