12 Exclusive Webinars on FDA Regulatory Requirements and Best Practices

Get guided on proper labeling guidelines for pet food manufacturers for compliance with FDA. Training on understanding ACE as the Sole CBP-Authorized EDI System for Processing Certain Electronic Entry and Entry Summary Filings Accompanied by FDA Data, the complex US entry process if you are planning to import FDA regulated products, FDA's New Quality Metrics Technical Conformation Guide, reporting format for the Quality Metrics and suggestions on how to use the metrics. Attend training session on regulatory and technical requirements for calibration, importance of a data-based calibration interval and limits of accuracy and precision; learn how the new FDA Guidance on Elemental Impurities' is related to ICH Q3D and USP Chapters 232 and 233 and more. This training package will explain how to label and promote a food or supplement without running afoul of laws, learn what stability testing is and when and how to conduct tests by attending this webinar. This training will explain the similarities and differences between the FDA and Health Canada GMPs that regulate the manufacturing of pharmaceutical products. Learn key medical device design controls by analyzing FDA 483 observations. Do attend this one hour webinar by Mercedes Massana. Get to know the significant facility design from the FDA and regulatory standpoint by attending this webinar and learn how to interpret and apply FDA New Draft Guidance Documents on Software and Device Changes and the 510(k).
Instructor: Kristina Lauzon, Dr. Rossano V. Gerald, John G.(Jerry) Lanese, Gregory Martin, Kenneth D. Weiss, Rachelle D'Souza,Jan Warner, Mercedes Massana, John R. Godshalk, Carolyn Troiano
Product ID: PACK70061

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?

  • Regulatory affairs personnel
  • Food packaging suppliers and manufacturers
  • Pet food suppliers
  • Labeling department personnel
  • Documentation experts
  • Food technologists
  • Food safety personnel
  • Food inspectors
  • Marketing personnel
  • QA/ QC personnel
  • 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
  • Compliance officers
  • Logistics/Supply chain managers and analysts
  • Trade regulatory/legislative affairs professionals
  • Sales/marketing personnel
  • Training personnel
  • Consultants
  • International business operations
  • Chief Executive Officers
  • Customs or Trade Compliance Personnel or Officers
  • Import or Global Trade Directors or Managers
  • Quality professionals
  • Senior corporate management
  • Auditors - all levels
  • Laboratory Managers
  • Research and Development scientists
  • Cosmetic Manufacturers and Distributers
  • Color Additive Manufacturers
  • Analytical & Microbiological Laboratories involved in Cosmetic / Cosmetic Ingredient Testing
  • Inspection Readiness/Preparedness
  • Sr. Directors/Directors
  • Compliance Professionals
  • Quality System Consultants
  • Systems Engineers
  • Engineering Managers
  • Documentation specialists
  • Manufacturing Engineers
  • Facility Manager
  • Validation Manager
  • Regulatory Manager
  • Design Team/Architects
  • Building Contractors
  • Information Technology Analysts
  • Business Stakeholders/Subject Matter Experts

Webinars included in the Package:

FDA's Pet Food Labeling Guidelines (Duration: 60 Minutes)

This session is designed primarily for pet food manufacturers and labelers, and is focused on helping you clearly understand what is expected by the FDA so that pet food manufacturers and processors are in compliance with these regulations. This session will cover the requirements of the FDA Department of Animal and Veterinary Guidelines for Industry.

Objectives of the Presentation:

  • Who is responsible for enforcing pet food labeling guidelines?
  • What responsibility does the FDA have in these regulations?
  • Do these guidelines differ in canned and dry foods?
  • What are the proper labeling guidelines for pet food manufacturers for compliance with FDA?
  • How are marketing claims for pet food defined?
  • What are the labeling rules for these marketing claims?
  • Importance of net quantity on the product label
  • Nutritional and caloric components to the product label for pet food
  • Feeding directions
  • What are the international pet food concerns and expectations?

Instructor Profile:

Kristina Lauzon is Currently employed as a Nutrition Manager in a LTC Home in Canada, Kristina is also a Chef. Before working as a Nutrition Manager Kristina worked in hospitality, healthcare & food processing. Her expertise includes Food Safety, HACCP, GMP's & Nutrition Science. Kristina enjoys studying Molecular Gastronomy & Neurogastronomy & Food Science.

Import FDA in the Automated Commercial Environment (ACE) Authorized Electronic Data Interchange (EDI) System (Duration: 90 Minutes)

This training event provides guidance on how to access FDA agency documentations that are addressing the strict requirements of imports of goods for health and safety reasons. These regulatory requirements may have an effect on the importer when it comes to the variety of product ingredients. For example, it will address the Automated Commercial Environment (ACE) as the Sole CBP-Authorized Electronic Data Interchange (EDI) System for Processing Certain Electronic Entry and Entry Summary Filings accompanied by Food and Drug Administration (FDA) Data by using reporting procedural and cases.

Objectives of the Presentation:

  • How to report in the ACE to ensure CBP import compliance
  • Tips on processing Electronic Data Interchange (EDI) System for Processing
  • How to do Entry Summary Filings of FDA import products

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. He is a Certified Supply Chain Manager, and Inventory Planner and Property Forecaster, Certified Consultant for Business Value Analysis and Methodology, Certified Export Leaders of the Free Trade Alliance and Casa of San Antonio, TX; Certified Master Management Consultant and Master Project Manager; and Certified Marketing Analyst and Registered Business Analyst by the International Management Consultant Certification Board (IMCB).

U.S. Import of FDA Regulated Products: Understanding the Entry Process (Duration: 90 Minutes)

Attend this webinar if you are importer of FDA regulated products or sell regulated products to U.S. importers and wish to have a better understanding of how FDA regulated products are entered into the U.S. Those new to importing FDA regulated products will also benefit from this webinar because we will explain some of the key terms, concepts and issues U.S. importers of FDA regulated products are likely to encounter. We will discuss 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.

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. He is a Certified Supply Chain Manager, and Inventory Planner and Property Forecaster, Certified Consultant for Business Value Analysis and Methodology, Certified Export Leaders of the Free Trade Alliance and Casa of San Antonio, TX; Certified Master Management Consultant and Master Project Manager; and Certified Marketing Analyst and Registered Business Analyst by the International Management Consultant Certification Board (IMCB).

Quality Metrics Program: FDA Challenges and Requirements including the New 'Quality Metrics Technical Conformation Guide' Released June 201 (Duration: 90 Minutes)

This program will allow the FDA to monitor several key metrics throughout the pharmaceutical industry without inspecting a facility. They will give FDA valuable insights into effectiveness of the Quality Control Laboratory, the quality culture of the organization, and the level of management involvement, and contribute to the risk analysis that will be used by the FDA to determine frequency of site visits. To date, in most firms, senior management has not been as involved with the day to day product production operations as is expected in a contemporary quality system model. The quality metrics will make the involvement of management in product realization operations and the Quality System more visible to the FDA. It will impact the culture of all pharmaceutical firms.

Objectives of the Presentation:

The objective of this webinar is to inform and educate the pharmaceutical industry community of the expectation of the FDA that all firms that produce a finished drug form or an API that is used in a finished drug form submit data that the FDA can use to calculate firm-specific quality metrics. This Quality Metrics program is justified by amendments to the Food, Drug and Cosmetic Act enacted in the FDASIA and will allow the FDA to monitor the activities without an on-site inspection an schedule risk based on-site inspections, based in-part on the Quality Metrics. This program is consistent with the FDA emphasis of the Pharmaceutical Quality System identified in ICH Q10.

Instructor Profile:

John G.(Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.

Laboratory Instrument Calibration: Current FDA Regulatory Requirements and Best Practices (Duration: 90 Minutes)

This web seminar builds on the terminology found in 21CFR160 (b)(4) and introduces terminology and concepts not found in the regulation, but necessary for an effective calibration program, such as instrument classifications. It applies measurement uncertainty or test accuracy ratio to specific calibration procedures and the selection of standards to provide scientifically sound calibrations traceable to national references. The discussion applies the concepts discussed to specific key instruments found in the testing laboratory.

Objectives of the Presentation:

Upon completing this webinar, the participant will understand:
  • The regulatory and technical requirements for calibration
  • What should be included in a calibration program
  • The importance of a data-based calibration interval and limits of accuracy and precision
  • The impact of measurement uncertainty when establishing limits of accuracy
  • The classification of test instruments
  • Current practices in the calibration of specific instruments

Instructor Profile:

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr.Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.

FDA's Update on Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines - Are you ready? (Duration: 90 Minutes)

FDA has issued a Draft Guidance on Elemental Impurities in Drug Products, which addresses ICH Q3D and USP General Chapters 232 and 233 on this topic. The Guidance makes recommendations on how to submit NDAs or ANDAs for non-compendial drug products, and how manufacturers of compendial drug products can comply with the new requirements. The similarities and differences between ICH Q3D and USP 232/233 are discussed, and recommendations are made for different categories of drug products, including compendial and non-compendial, and those approved under an NDA/ANDA or not approved under an NDA/ANDA. A risk-based approach to the control of elemental impurities is advocated, which informs which elements are likely to be present and what controls are appropriate. The guidance also addresses validation of analytical procedures and early adoption of the standards.

Objectives of the Presentation:

  • How the new FDA Guidance on Elemental Impurites is related to ICH Q3D and USP Chapters 232 and 233
  • What drug products are within the scope of the guidance
  • Which classes of drug products need to comply with ICH Q3D and which with USP 232/233
  • How risk assessment influences what testing is required
  • What documentation related to control of elemental impurities is expected by FDA
  • Which procedures can be used to demonstrate compliance
  • How methods should be validated

Instructor Profile:

Gregory Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

Substantiation of Food and Supplements Marketing Claims: FDA and FTC Requirements (Duration: 60 Minutes)

Nearly all training on claims is given by attorneys. They provide extensive, accurate information, but often it is hard to understand and too detailed for managers of small companies. This webinar will explain, in layman's terms, how to label, advertise and promote a food or supplement without running afoul of laws that are enforced by agencies such as the U.S. Department of Agriculture, the Food and Drug Administration, the Federal Trade Commission and the U.S. Department of Justice.

Objectives of the Presentation:

  • What they can and cannot say about their products
  • Which kinds of products are most subject to evaluation of claims
  • To avoid problems with product labeling, advertising and other types of promotion
  • Which government entities might be evaluating their claims
  • Whether and how they can use testimonials in advertising
  • Sources of additional information

Instructor Profile:

Kenneth D. Weiss is a consultant and writer in marketing and international trade. He has worked with many products and has special expertise in foods and beverages. His works include market research and information, helping his clients comply with a variety of U.S. regulations and connecting them with potential business partners.

Cosmetic Testing for US FDA Compliance (Duration: 60 Minutes)

The US Food and Drug Administration (FDA) holds cosmetic manufacturers and distributors responsible for the safety and quality of their cosmetics. This webinar serves to guide cosmetic manufacturers and distributors as well as other entities such as color additive manufacturers and analytical and microbiological laboratories on FDA recommendations and requirements concerning the safety and quality testing of cosmetics. Topic areas covered in this webinar include, FDA considerations for microbiological testing, animal testing, potential contaminants, nanomaterials in cosmetics, cosmetic good manufacturing practices (GMP) compliance testing, shelf life/expiration dating, select cosmetic ingredients and color additive batch certification.

Objectives of the Presentation:

To ensure safety and quality of a cosmetic/cosmetic ingredient and achieve compliance with the US FDA, specifically by covering the following FDA topic areas:
  • Microbiological Testing for cosmetics
  • Animal Testing & Cosmetics
  • Potential Contaminants
  • Color Additives & Batch Certification
  • Select Cosmetic Ingredients: Prohibited & Restricted Ingredients
  • Shelf Life/Expiration Dating
  • Nanomaterials in Cosmetics
  • Cosmetic Good Manufacturing Practices (GMP) Compliance Testing

Instructor Profile:

Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national companies. Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety/pharmacovigilance and medical information systems

FDA Vs Health Canada (Duration: 90 Minutes)

If you are in the US or Canada and either manufacture pharmaceutical products for your country or distribute to either the US or Canada, you will understand the requirements. This webinar will be the first step in unraveling the keys to successful interactions with the US FDA and Health Canada officials. The training will discuss similarities and differences between the two agencies. Compliance in these areas have been shown to lead to successful FDA and Health Canada inspections and this course will explore cultural considerations that have been proved to be helpful.

Objectives of the Presentation:

  • Short History - FDA
  • Short History - Health Canada
  • Similarities between FDA and Health Canada
  • Differences between FDA and Health Canada
  • Cultural Considerations
  • Successful Interactions

Instructor Profile:

Jan Warner is an accomplished, broad-based regulatory, quality and compliance professional with over 25 years of experience in the following products and industries: pharmaceutical, medical device, OTC and personal care, homeopathic drugs, dietary supplements and cosmetics. He has held numerous upper management responsibilities in quality assurance, compliance and quality control at companies such as Pall Corporation, Luitpold Pharmaceuticals, Axiom Pharmaceuticals, Johnson and Johnson and Nobel Biocare. Jan has extensive experience working for Fortune 500 as well as start-up companies.

Learning Design Controls through Review of FDA 483 Observations (Duration: 75 Minutes)

Meeting design control requirements is essential to the success of any medical device company. For those that need a primer on where to focus their efforts, the best way to learn about design controls is from the mistakes that other companies have made and been cited FDA 483 observations for, so that these same mistakes can be avoided. Breaking down the FDA 483 observations yields a trove of information as to what is important to FDA that medical device manufacturers are not doing correctly.

Objectives of the Presentation:

  • Design and Development Planning
  • Design Inputs
  • Design Output
  • Design Reviews
  • Design Verification
  • Design Validation
  • Design Transfer
  • Risk Management

Instructor Profile:

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over thirty years of experience in the Medical Device industry; Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems.

Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects (Duration: 60 Minutes)

This course explores some of the best practices of pharmaceutical and biologics facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements will be discussed and the reasoning behind them. Examples of floor plans and flows (people, product, etc.) will be examined and discussed. Specifics for fixtures, finishes, HVAC and other design aspects of cleanrooms will be discussed in terms of current practices and GMP requirements. Examples of design choices for pressurization, flows and HVAC zones will be given along with their possible application. Design specifications for both open and closed systems will be discussed along with current standards.

Objectives of the Presentation:

  • Best design practices for pharmaceutical facilities
  • Best design practices for biologics facilities
  • Regulatory compliance for Pharma and biologics facilities design
  • Flow patterns and cross contamination controls
  • Design criteria for fixtures and finishes
  • Examples of good design
  • General specifications for different classification zones
  • Examples of design specs for cleanrooms

Instructor Profile:

John R. Godshalk currently works for the Biologics Consulting as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy and guidances. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and cGMP compliance approaches that meet FDA licensing requirements. John received his B.S. in chemical engineering from N.C. State University and his M.S.E. in biochemical engineering from Johns Hopkins University.

FDA's Two New Draft Guidance on Software and Device Changes and the 510(k) (Duration: 90 Minutes)

The attendee will learn the key aspects of the two new draft guidance documents from FDA, including specific recommendations for how to assess the level of risk associated with the product and the change to it. The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided.

Objectives of the Presentation:

  • To learn how to interpret and apply the two draft guidance set forth by FDA on submission of a 510(k) for changes to medical devices and/or software used in conjunction with medical devices
  • To understand the impact this guidance will have on the development, management and use of medical devices and software used in conjunction with medical devices that have been modified
  • The course will provide useful information to medical device and software developers who manage changes to these devices and/or software
  • The audience will learn what device changes and/or software changes will likely require the submission of a 510(k) and what ones will not
  • We will discuss when and how the draft guidance documents should be applied in industry

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.

Price:$2000.00
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