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Dietary Supplement Good Manufacturing Practices (GMP) for Laboratories

Ensuring Regulatory Compliance

Presented by Charlotte Peyton, Independent Consultant

March 1-3, 2022, from 12-4:30 pm eastern each day

EAS is offering an intensive virtual seminar covering FDA’s current Good Manufacturing Practice (GMP) requirements for Research and Development and Quality Control Laboratories. Topics include GMP regulations for physical, analytical, and microbiological laboratories including analyst training and qualification; the labs’ physical facility and environment; instrument qualification, calibration and maintenance programs; laboratory sample control processes; the management of standards and chemicals; the management of data; and overall laboratory documentation. The development, verification, validation, control, and use of test methods as well as transfer thereof will also be discussed.

An entire session will be dedicated to the performance of thorough, timely, unbiased, well-documented, and scientifically sound Out-of-Specification (OOS) investigations since this is one of the most critical laboratory quality systems. Tips regarding establishing quality agreements with clients and handling the FDA during an inspection will also be provided.

FDA issues of concern will be highlighted throughout the program with emphasis placed on recent FDA regulatory or administrative actions. All of this will allow participants to gain an understanding of the importance of laboratory GMPs and how to meet FDA’s requirements.

Who Should Attend

This program will benefit those involved in the Regulatory Affairs, Quality Control/Quality Assurance, Manufacturing, Research & Development, Validation/Qualification, laboratory analysts, supervisors and managers. It will be of particular interest to those charged with implementing, validating and maintaining laboratory compliance programs.

Agenda

Agenda
Day 1, 12-4:30 pm eastern
  1. Introduction and GMP Overview
  2. Personnel
  3. Laboratory Facility, Equipment, and Instrumentation
  4. Sample Tracking
  5. Chemical and Standards Management
  6. Documentation and Data Management
  7. Quality Incident Systems
Day 2, 12-4:30 pm eastern
  1. Specifications and Testing
  2. Material and Product Qualification
  3. Test Method Validation / Verification
  4. Out of Specification Investigations
  5. Stability Programs
  6. Being or Using a Contract Laboratory

Work Session

Laboratory GMP Exam

Registration

 

$549.00$599.00

Clear
All seminar registrations are per person.

Discounts

Two or more registrants from the same company – 10% use GROUP10 discount code at checkout)

Federal and State Government employees use GOV50 for a 50% discount*

* only one discount code may be used

Cancellations

EAS reserves the right to cancel the seminar if minimum participation has not been met two weeks prior to the start of the seminar. All registrations will be refunded in full.

Cancellations will be refunded minus a $95 processing fee up to two weeks prior to the start date of the seminar. After this date, no refunds will be given.

Terms and Conditions
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On-line Training
EAS Consulting Group seminars are conducted virtually through Zoom. A link will be provided to each participant. To ensure an understanding with the instructional material, live student attendance and active participation in discussions via webcam is required. Students will demonstrate an understanding of learning objectives prior to receipt of any certificate of training.

About the Presenter

Charlotte Peyton

Charlotte Peyton supports EAS dietary supplement and pharmaceutical clients from startup and growth through manufacturing and manufacturing support. Her expertise includes quality, regulatory and management, method development and method validation for FDA regulated drug, dietary supplement, and bioanalytical samples. She has extensive experience in writing validation protocols, reports and SOPs and assists with implementation of stability programs and report writing for drug and dietary supplement finished products.

Posted in Dietary Supplements, Seminar.