Next Upcoming Webinar: What is a Scientifically Valid Method Part 3 of a 5 Part Webinar Series – October 30, 2017

Specializing in FDA Regulatory Matters

In-House Training

EAS offers a wide variety of in-house training programs to fit your company’s specific needs. Choose from one of our prepared trainings or allow our experts to design a custom training for you. Call EAS at (571) 447-5500 to learn more.

Drugs

OTC cGMP Compliance Review Seminar

EAS presents a one and one-half day intensive program discussing FDA’s current Good Manufacturing Practice requirements and recent inspection findings for human OTC drug products. The course will cover the FDA regulations Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century, Quality Risk-and Science-Based Approaches, Pharmaceutical Development and Pharmaceutical Quality Systems. Participants will gain an understanding of cGMP requirements and FDA’s enforcement of the regulations. FDA issues of concern will be highlighted throughout the seminar with emphasis placed on recent FDA regulatory and administrative actions. FDA investigator observations, as well as problems in dealing with FDA inspections, will be illustrated in the case studies presented.

At this Seminar You Will:

  • Learn the requirements of the regulations.
  • Gain an understanding of how FDA is enforcing the regulations.
  • Receive detailed practical guidance on how to apply these requirements.
  • Be given an opportunity to demonstrate your understanding of GMPs in case studies
  • Be coached on how to prepare for an FDA inspection and how to avoid receiving a List of Objectionable Inspection Observations (Form FDA 483) at the end of an FDA inspection.

Finally, there will be a discussion of responding to FDA 483s and Warning Letters.

Marketing and Labeling OTC Drugs and Cosmetics in Compliance with FDA Regulations

OTC Drug and Cosmetic products have come under increased FDA scrutiny. How well do you know current Cosmetic and OTC Drug regulations and regulatory trends? Are your labels in compliance with requirements? How can you keep on top of the latest labeling issues?

Learn cosmetic and OTC drug labeling and compliance from former FDA officials who helped shape current labeling regulations and who understand compliance issues. This hands-on, two-day seminar covers the basics of how cosmetic and OTC drug products are regulated and what is needed to comply with the complex set of labeling rules. The seminar introduces the latest in cosmetic and OTC labeling issues that have gotten attention from FDA and provides answers to your most challenging questions.

At the Seminar, You Will

  • Understand OTC and Cosmetic compliance and labeling requirements from experts who helped to develop and implement the current regulations and have reviewed hundreds of regulatory issues for the industry.
  • Learn about Cosmeceuticals, what’s permitted, and how to avoid trouble.
  • Understand the OTC Monographs and how they can be used to your advantage in marketing your product.
  • Learn about hot issues that have triggered recent FDA warning letters.
  • Have your specific issues addressed and discussed in a casual, interactive learning environment.

Drug GMP Compliance

FDA ensures the quality of pharmaceuticals in the US marketplace through a system of Good Manufacturing Practices (GMPs), a system it takes very seriously. These GMPs provide a standard by which all pharma companies must operate, from handling raw materials, the safety and security of the facilities to testing and validation of equipment and product which together helps to prevent contamination, mix-ups, deviations, failures, and errors.

While drug GMPs are a standard across the industry, understanding how to apply them in each setting is unique as each company is able to determine how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures suitable for their business. EAS Drug GMP Compliance seminar offers an opportunity for a tailored approach, taking these regulations and applying them to your unique manufacturing situation, whether manufacturing an active ingredient or a finished product.

In the EAS Course you will:

  • Understand each component within pharmaceutical GMPs and how they can be implemented in your business
  • Have an in-depth discussion on how to validate results and calibrate equipment to ensure quality is maintained
  • Discuss how to capture and track adverse events reporting
  • Develop a checklist to prepare for FDA inspections and 483 Warning Letters

Preparing for FDA Pre-IND Meetings – Steps for Success

Pharma companies with aspirations to study and launch a new product must seek and gain approval from FDA prior to initiating phase 1 study of their Investigational New Drug (IND). The planning and preparations prior to these meetings is immense, as FDA looks for specific criteria indicating due diligence in the design and execution of safety studies, data tracking as well as how results are compiled, mined and presented for FDA consideration.

Learn how to strategize and prioritize the steps to preparations for an FDA Pre-IND meeting from EAS pharma experts who have had successful careers in both industry and FDA.

In this course you will:

  • Learn the structure and goals of pre-IND meetings
  • Prepare your company’s checklist for required documentation
  • Anticipate FDA’s questions for better preparation
  • Understand “best practices” for navigating and communicating with FDA throughout the Pre-IND process

Pre-FDA Inspection – Preparation, Validation, Qualification

Notification of an FDA inspection creates concern that all processes are adequate to meet stringent standards. Even the best-prepared companies can still have a moment of doubt that their best-laid plans have left out a critical component.

EAS Consulting Group’s Pre-FDA Inspection Seminar – Preparation, Validation, Qualification helps companies prepare for an FDA inspection before FDA walks through the door. Our team of experts, former FDA compliance and inspection officials and industry executives, prepares your in-house experts on the detailed analyses and checks that FDA will be combing through to ensure all applicable requirements are being met or exceeded.

In this seminar you will:

  • Understand what to expect in an FDA inspection
  • Take a close look at your processes, systems and procedures to ensure you are meeting FDA requirements and developing an improvement plan in advance of the inspection for those items that do not
  • Understand the what’s and how’s of qualification and how to ensure results are appropriately validated
  • Understand how best to collect and track adverse events reporting
  • Set-up internal documentation structures so that FDA may easily access required information
  • Discuss on 483 Warning Letters and required responses

Dietary Supplements

Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar

The FDA conducted nearly double the number of facility inspections for Dietary Supplement Firms in 2012 over 2011 and issued approximately 38 Warning Letters.  In light of increased FDA oversight, a thorough review of new industry rules on good manufacturing practices (GMPS) is warranted.

EAS Consulting Group will be conducting a Dietary Supplement GMP Seminar to help firms prepare for increased FDA enforcement. Given by former FDA compliance officials and industry experts, this intensive training program will provide all the information needed to comply with the rules, covering the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved in the testing, quality control and distribution of supplements.

At the Dietary Supplement GMP Seminar, You Will

  • Learn the requirements of the final Rule and understand how they differ from the proposed rule that was published in March 2003
  • Receive detailed practical guidance on how to apply these requirements.
  • Be given an opportunity to demonstrate your understanding of GMPs in group work sessions Be coached on how to prepare for an FDA inspection and how to avoid receiving a List of Objectionable Inspection Observations (Form FDA 483) and the end of an FDA inspection.

Good Manufacturing Practices in the Dietary Supplement Laboratory

EAS Consulting Group offers a one-day intensive seminar on Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. Learn how to establish and maintain, or identify, an adequate laboratory facility with effective laboratory controlled processes that follow thorough, detailed written procedures. Get a basic understanding of what analytical techniques are available and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met. Find out what a scientifically valid test method is and how to experimentally demonstrate it. When specifications are not met, learn how to conduct a scientifically sound out of specification (OOS) investigation. Finally, understand what it takes to sustain good documentation practices in a laboratory setting.

Covering topics such as:

  • 21 CFR 111 GMP Laboratory Overview
  • Using Analytical Instrumentation Appropriately
  • What is a Scientifically Valid Method?
  • Developing Compliant Specifications – No “By Inputs” Here
  • How to Select and Qualify a Contract Laboratory
  • Conducting a scientifically sound out of specification (OOS) investigation.

Attendees will leave with a clear understanding of how to improve processes in their laboratory and how those improved processes can lead to a more compliant product.


Food

FDA Nutrition Labeling Revisions and Impact on Food Label Claims

For the first time in more than two decades, FDA has updated the Nutrition Facts label found on most food packages in the U.S. with three regulations update: revision of the Nutrition and Supplement Facts labels and changes in some of the serving sizes of foods. Two of the new regulations have a major impact on the food industry requiring an estimated 800,000 labels to be updated.

EAS is ready to assist you in compliance with these important changes including formatting, mandatory nutrients, added sugars, dietary fiber, folate, and serving sizes. Our newest training, FDA Nutrition Labeling Revisions and Impact on Food Label Claims which focuses on the 2016 Nutrition Labeling Final Rules, offers an in-depth discussion of the required Nutrition Facts Panel and Supplements Facts Panel revisions as well as opportunities and challenges for new claims and existing nutrient content claims based on Daily Values. The impact on the “healthy” claim and authorized health claims will also be discussed. Students will come away with a step-by-step plan on how to “tackle” the conversion from the old Nutrition Facts Panel format to the new.

Taught by expert EAS labeling consultants, this one-day seminar will help you gain the most important information necessary to understand required changes that must be made to your product labels in order for them to be in compliance with FDA’s newest requirements.

At this Seminar you will:

  • Learn FDA’s latest labeling requirements from regulatory experts.
  • Be able to ask questions of former FDA officials to get an understanding of how the Agency thinks.
  • Receive a valuable Participant’s Manual containing all slides and handout materials that will save you time and help assure your labels are in compliance.
  • Get an opportunity to apply learning in practical work sessions.

USDA Labeling Compliance Seminar

Working with meat and poultry products and not sure how to go about labeling your products? Not sure if you meet a food standard? Join EAS Consulting Group experts for a one-day training program that explores the world of USDA food labeling  You will learn what required features need to be on the label if you need to qualify the product name and even where to look up food product standards. We’ll also touch on hot topics such as natural, allergens and gluten-free.

At the Seminar You Will Learn:

  • The features required on a USDA label
  • When Qualifiers are needed in the product name
  • Where to find the standards for USDA products

FSMA Part 117: Preventive Controls for Human Food for Managers

EAS intensive one-day training seminar, FSMA Part 117: Preventive Controls for Human Food for Managers, is geared specifically for executives and managers and details the broad oversight of how preventive controls for human food required under Part 117 of the Food Safety Modernization Act (FSMA) should be managed in an organization. Attendees will leave with a clear understanding of their role and how to better manage the implementation of the new part 117 preventive control regulations.

The topics will include:

  • An introduction to FSMA & Part 117 Elements
  • Subpart A – General Provisions
  • Subpart B – Good Manufacturing Practice
  • Subpart C – Hazard Analysis and Risk-Based Preventive Controls (HARPC)
  • Subpart D – Modified Requirements- Warehouses
  • Subpart G – Supply Chain Program
  • Subpart F – Recordkeeping Requirements

FSMA Part 117 Compliance for Dietary Supplements

FSMA’s preventive controls rule, 21 CFR 117.5(e), exempts finished dietary supplements (DS) from the requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111, and with adverse event reporting. Exemption from these two elements of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA.

EAS one-day seminar, FSMA Part 117 Compliance for Dietary Supplements will cover the elements of FSMA with specific applicability to the dietary supplement industry, with information geared to the various roles within a food manufacturing facility. Attendees will leave with a clear understanding of their role and how to better manage the implementation of the new part 117 preventive control regulations.

  • An introduction to FSMA & Part 117 Elements.
  • Subpart A – General Provisions.
  • Subpart B – Good Manufacturing Practice.
  • Subpart C – Hazard Analysis and Risk-Based Preventive Controls (HARPC).
  • Subpart D – Modified Requirements – Warehouses.
  • Subpart G – Supply Chain Program.
  • Subpart F – Recordkeeping Requirements.

Cosmetics

Cosmetic GMP Overview

The many aspects of the cosmetics industry are self-regulated, one area that must meet or exceed compliance standards are those of Good Manufacturing Practices (GMSs). An FDA inspection that finds deficiencies in the buildings and equipment, personnel raw materials, production, laboratory controls, documentation color safety and complaint procedures will receive at best a Warning Letter with written deficiencies that must be corrected or injunctions or recalls against the sale of the product in U.S. commerce.

EAS offers a Cosmetic GMP Overview seminar which covers the details of what must be adhered to and how companies should document their compliance with FDA standards.

At this EAS course you will:

  • Gain an understanding of Cosmetic GMP requirements and how FDA enforces them
  • Understand the frequency of required laboratory tests and how to interpret, utilize the results
  • Develop or refine SOP protocols for all aspects of operations
  • Understand record keeping and access requirements
  • Learn how to best track and report adverse event reporting
  • Develop a plan for FDA inspections and discuss responses to 483 findings