Pack of 16 Best Seller Webinars on All FDA Related Regulations and Requirements

These set of courses are intended to provide you with all the FDA related regulations, compliance and requirements. Critical issues will be discussed so you can develop and maintain effective and efficient compliance. These topics will cover legal requirements which will include FDA auditing, investigations, social media marketing, SOPs, TMS, 501(k) requirements, import and export requirements, Spreadsheet and electronic record maintenance and much more.
Instructor: Luis Chavarria, Mukesh Kumar, Casper E Uldriks, Stephen Schwartz – CIC, David Lim, Carolyn Troiano, Dr. Rossano V. Gerald, Alfonso Fuller.
Product ID: PACK70064
Webinar Topics Included:
1. FDA Investigations and Inspections
How FDA conducts investigations and inspections. Learn about the tools and procedures the FDA uses to conduct investigations and inspections from a former retired FDA Office of Regulatory Affairs officer.

Objectives of the Presentation:
Attend to familiarize yourself and your staff with the specific areas, and processes covered by FDA staff during the investigations and inspections and also in the advent of a future inspection or investigation of your company.

Instructor Profile:
Mr. Luis Chavarria recently retired from the United States Food and Drug Administration (FDA) after more than 30 years of service. His unique career covered numerous national and international assignments.
2. Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements
21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides basic framework for computer systems used to generate records and data, and used for analysis and presentation.

Objectives of the Presentation:
  • Part 11 requirements by FDA
  • Applicable systems per the FDA
  • Validation of computer systems
  • Network set-up, maintenance, integrity check and security
  • Common elements of Part 11 complaint computer systems
  • Building Part 11 compliant systems bottom-up and top-down
  • Back-up and re-creating data
  • Verifiable audit trails
  • Electronic signatures and certificates
  • Best practices for using non-networked computers
Instructor Profile:
Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD., who expertise is in developing Global Regulatory Business Strategies for biomedical product development.
3. FDA Import and Export Requirements
Critical issues will be discussed so you can develop and maintain an effective and efficient import / export business. The topics cover legal requirements and practical business operations. Given the FDA's increased scrutiny of international trade, understanding the following topics is essential.

Objectives of the Presentation:
The webinar covers critical issues that any FDA regulated firm should understand to survive regulatory scrutiny. Awareness of the topics, at a minimum, will help you ensure your compliance profile import/export practices and, where appropriate, the need to improve it.

Instructor Profile:
Casper E Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs.
4. FDA Rules for using Social Media for Marketing Prescription Products
Social media offers an excellent opportunity for a company to get the word out about its drugs, biologics, medical devices and diagnostic kits. However, FDA regulated products need to follow strict information control; any information distributed to consumers must be approved by FDA.

Objectives of the Presentation:
  • How Direct-to-consumer-advertising ("DTCA") guidance impacts the use of social media
  • Common ways companies are currently using social media
  • FDA advertising and promotion issues related to social media
  • A structure for analysis of responsibility for promotion in social media
  • Handling unsolicited requests for off-label information
  • Recent trends in FDA enforcement actions involving social media
  • Recent discussions about social media in marketing of FDA-regulated products
Instructor Profile:
Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD., whose expertise is in developing Global Regulatory Business Strategies for biomedical product development.
5. Preparing for an FDA Audit of your facility
Each year FDA audits more than 16,000 facilities involved in manufacture, testing or development of food and drug products, and collects more than 25,000 product samples for analysis at its labs. These include not only drugs and biologics but also medical devices, diagnostic kits, dietary supplements, veterinary products, and animal and clinical testing facilities.

Objectives of the Presentation:
  • Types of FDA audits
  • Key guidelines available from FDA
  • Preparing for the inspection
  • Logistics of the FDA audit
  • Follow-up to an FDA audit
  • Do's and don'ts of an FDA audit
Instructor Profile:
Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD., whose expertise is in developing Global Regulatory Business Strategies for biomedical product development.
6. 10 Steps to Perfect SOPs: FDA Compliance made easy
Formal and written Standard Operating Procedures (SOPs) are keystones for good operations. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand.

Objectives of the Presentation:
  • Essential elements of an SOP
  • Process mapping techniques to define the contents of an SOP
  • Role of personnel in creating SOPs
  • SOP revisions, updates, creation, retirement and documentation
  • Categorization of SOPs
  • Assessment of compliance techniques
  • Training practices for FDA compliance
  • Access and access control to SOPs
Instructor Profile:
Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD., whose expertise is in developing Global Regulatory Business Strategies for biomedical product development.
7. Label Uses of Medical Products Under FDA Rules: Walking the Fine Line of Promotion Verses Scientific Discussion
FDA has publicly acknowledged that many regulated products have uses beyond what they have been approved for. FDA also recognizes that these unapproved uses may be beneficial to some patients.

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 leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD., whose expertise is in developing Global Regulatory Business Strategies for biomedical product development.
8. FDA Rules for Trial Master Files
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.

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 leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD., whose expertise is in developing Global Regulatory Business Strategies for biomedical product development.
9. FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products
This seminar will highlight the key elements of rules governing HCT/Ps using case studies. Practical suggestions for compliance with the FDA requirement along with tips to negotiate with the agency regarding disputes with interpretation of the law will be discussed.

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 leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD., whose expertise is in developing Global Regulatory Business Strategies for biomedical product development.
10. Using Excel Spreadsheets in FDA Regulated Environment
This seminar provide insight into regulatory requirements and inherent limitations in “Out of the Box” Excel, validation techniques, documentation requirements, and risk-based evaluation of Excel spreadsheets. Practical strategies and case studies will be used to highlight common issues and potential solutions.

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 leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD., whose expertise is in developing Global Regulatory Business Strategies for biomedical product development.
11. Fundamentals of the new FDA inspectional record requirements for EDC and EDE clinical trials
This webinar deals with basics of new FDA inspectional record requirements for EDC/EDE clinical trials. Case history of multiple site trial that uses EDC to be presented. For electronic record function procedures, changes might be possible to remain in compliance with the compliance inspectional standards.

Objectives of the Presentation:
  • Does the new guidance reduce or change the burden of documentation for investigators and sponsors where electronic records/ case histories/ source documents are utilized?
  • Exactly what study data do not now require source documentation?
  • What original source documentation is still required for an inspection?
Instructor Profile:
Stephen Schwartz – CIC founder of Commonwealth Clinical Research Services (later as Solaris Research Corporation), a full service CRO from 1989 to 2009. He has a degree in microbiology/infectious disease and has worked in clinical project development for Pharma for 16 years and for 20 years as a CRO with experience in devices, biologicals, diagnostics, and therapeutics in most of the areas of clinical research for all study phases, as well as pre-clinical activities.
12. Understanding FDAs Recent 510(k) Guidance and New Requirements
This webinar 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.

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.
13. 21 CFR Part 11 Electronic Records/Electronic Signature and FDA-Regulated Computer Systems
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 regulated environment.

Objectives of the Presentation:
  • 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
  • Best practices and principles for establishing and maintaining computer system compliance while using ER/ES capability in an FDA-regulated environment
  • 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.
14. U.S. Import of FDA Regulated Products: Understanding the Entry Process
This trade webinar will explain the complex US entry process so companies that import FDA regulated products will benefit from a better understanding of how the process works. It will discuss factors and actions that can lead to an import shipment being delayed or not allowed entry into the USA.

Objectives of the Presentation:
  • How to manage the entry process to ensure import compliance and timely release of merchandise
  • Tips on classifying FDA regulated products
  • How to find an FDA import product code
Instructor Profile:
Dr. Rossano V. Gerald is an Academic Professor and Founder of RVG International Consulting Firm, LLC. He has over twenty five years of business experience in, strategic management, marketing analysis, and supply chain management.
15. Spreadsheet Validation: Understanding and Satisfying FDA Requirements
This webinar will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements.

Objectives of the Presentation:
  • Understand the significance of spreadsheets as software as viewed by US FDA
  • Review current FDA posture towards spreadsheets
  • Know how to conduct an audit of the use of spreadsheets in the organization
  • Recognize when spreadsheets being used should conform to FDA regulations
  • Be able to determine which spreadsheets are not required to be validated, and how to document
  • Be able to determine which spreadsheets do not trigger 21 CFR part 11 compliance
  • Know the relationship between spreadsheets and SDLC
  • Review the relationship between "validation" and "part 11 compliance"
  • Be able to plan spreadsheet validations, and integrate into overall validation planning
Instructor Profile:
Alfonso Fuller is the President of Fuller Compliance, Inc., a consulting firm that specializes in FDA quality system, software validation and software quality for pharmaceutical, biotech and medical device, nutraceutical and food manufacturers.
16. FDA's Off-label Promotion in Social Media
The webinar provides insight on how to manage marketing strategies that use social media. A firm's use of social media faces FDA restrictions and obligations on how you use social media, what you can say and what you must do to correct misinformation published by third parties that places you at risk with FDA.

Objectives of the Presentation:
  • How FDA limits the use of social media
  • How social media can make your product illegal (misbranded)
  • Who triggers the off-label trap
  • Figure out who is responsible for false or misleading information
  • Identify corporate controls over regulatory affairs and marketing departments
Instructor Profile:
Casper E Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs.
How It Works:
  • Recorded sessions will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Links are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Reference materials for Webinar Recording will be mailed to your registered e-mail id
Who will benefit?
  • Staff in FDA regulated industries that are subject to inspections
  • FDA-regulated labs, clinical trial sites, manufacturers, and sponsors
  • Everyone involved in computer system validation
  • Anyone selecting computer systems intended for FDA regulated environments
  • Information technology professionals responsible for files or network locations
  • Executives evaluating requirements Part 11 compliant systems
  • Corporate import/export managers
  • Financial planning managers
  • International shipping managers
  • Import brokers
  • Foreign manufacturers
  • Attorneys – In-house or Outside Counsel
  • Sales Vice presidents, Directors and Managers
  • QA/QC/Compliance/Regulatory affairs professionals
  • Senior management executives (CEO, COO, CFO, etc)
  • Manufacturing managers, supervisors & personnel
  • Clinical and preclinical laboratory managers
  • Clinical trial specialists
  • Project Managers
  • People investing in FDA-regulated product development projects
  • 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
  • Senior management for companies developing new products for US market
  • Research analysts
  • Data Managers
  • Principal Investigators
  • Sponsors of INDs
  • People investing in FDA-regulated product development project
  • Managers and owners of HCT/P marketing companies
  • Hospital and clinics using HCT/Ps
  • Regulatory, compliance and quality professionals consulting with HCT/P companies and working in HCT/P manufacturing sites
  • Medical insurance and reimbursement professionals
  • Physicians and consumers using HCT/Ps
  • System owners and personnel who create or use spreadsheets in FDA regulated areas
  • IT / IS managers and personnel
  • Software quality reviewers
  • Medical Record personnel
  • Clinical CRA Monitors
  • Clinical Program Managers
  • Clinical Quality Assurance Auditors
  • R & D (engineers, scientists, managers, directors or VPs)
  • Complaint and risk management personnel
  • Consultants
  • Contractors/subcontractors
  • Clinical affairs (associates, specialists, managers, directors or VPs)
  • Other interested parties
  • Organizational change managers
  • Business process engineers
  • Analytical chemists
  • Lab managers
  • Automation analysts
  • GxP training specialists
  • U.S. importers of FDA regulated products
  • New U.S. importers of FDA regulated products
  • Foreign exporters of FDA regulated products (companies which sell regulated products to U.S. importers)
  • Purchasing department personnel for U.S. importers of FDA regulated products
  • Logistics/Supply chain managers and analysts
  • Trade regulatory/legislative affairs professionals
  • International business operations
  • Customs or Trade Compliance Personnel or Officers
  • Import or Global Trade Directors or Managers
  • Import Supervisors
  • Production and Process Engineers
  • Manufacturing Engineers
  • Design Engineers
  • Purchasing Managers
  • Purchasing Agents
  • Supplier Quality Engineers
  • Third-party consultants
  • Own Label distributors
  • Product specification developers
  • Corporate web managers
  • International trade managers (imports and exports)

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