GMP Training

Instructor

Dr. Bill Spanogle  |  Biotech Research Group

Bill is a highly accomplished, adaptable C-Level Advisor and hands-on leader in the full spectrum of Regulated Life Sciences Product & Process Development, RA/QA, EU-MDR/IVDR, QbD, and CSV-GAMP-Part11. Bill has successfully characterized and taken scores of medical devices, Biotech, Pharma, and Combo Products, Designs, Materials, & Processes from concept through commercialization via QbD, Design Controls, Risk, PMS, CER, PRRC, data trending, submissions, site inspections, turnarounds, and all intermediate functions. He is a recognized international & domestic invitational Biotech, medical device, Combo, CSV, and regulated life science leader, presenter, assessor, remediator, instructor, implementor, and author. Those who have and do work with Bill, continually nickname him “Doctor Bill” for his passion, skills, integrity, and compassion in effectively aligning and harmonizing people and organizations within the regulated life science Industry. Bill’s Regulated Life Sciences background includes, but not limited to, Management, Leadership, and Director Levels for J&J Medical Devices, Biotech, Stem Cells, IVDs; turnaround of Carefusion, and IVD Submissions Serono-Baker, respectively. These experiences span several decades, multiple continents, numerous International Regulatory Bodies. His Medical Device Design Control expertise has its roots in his nearly five years of Software Design and Development and Controls. To-date Bill has led and guided >4000 professionals, across multiple global Sites, in Design Controls, CSV, Part 11 GAMP & QbD, and 1000s of professionals as an Invitational Presenter at numerous Professional Conferences, and 1000s more via publications and ISPE Guide Series.

Certificate

All participants who successfully complete the course will receive a Certificate of Completion in “Current Good Manufacturing Practices,” a valuable and required credential for employers and regulatory agencies.

Objective

During this Live Online Training Course, a subject matter expert will share their expert knowledge about important aspects of current Good Manufacturing Practices. In this course you will learn the most important pharmaceutical and medical device regulations and their importance, get a basic overview of GMP requirements in production and become familiar with technical terms from the field of GMP and their meaning.

Background

Current Good Manufacturing Practices (cGMP) are guidelines that regulate the production of drugs and medical devices to ensure that they are produced in a safe manner. During this training, you will learn how they shape the everyday procedures that oversee any given company’s work in this field. The organizational structure necessary for work to be performed under cGMP will be explained. Facilities and the appropriate requirements needed to operate each will be discussed in a broad view. Procedures, their requirements and their structure will be reviewed to ensure that the work done at your facility will meet cGMP guidelines. Knowing what each person’s responsibilities and duties are will ensure that the right work is done by the right person at the right time. Finally, we will review how all of this work should be documented, so that people know what is going on at a given company.

 

This Live Online Training Course has been designed by AAQF to provide useful information which is needed for an efficient management of regulated products.

Target Group

• Managers and executives
• Manufacturing Staff
• Packaging Staff
• Labeling Staff
• Regulatory Affairs Staff
• Laboratory Staff
• Quality Control/Quality Assurance Staff

Technical Requirements

AAQF uses Zoom for our live online training courses and webinars. After successful registration, you will receive a link with all the Information you need to participate in AAQF trainings, and you can check if your system meets the necessary requirements to participate. Zoom can be accessed by their application or by any browser (Google Chrome works best). Zoom is a standard method for training and is fast and easy to access.

Program

Day 1

 

Session 1 (0900-1200)

• Typical expectations of FDA inspectors
• Personnel and Training
• General aspects
• Qualification
• Key personnel
• Job descriptions
• Training (purpose, goals, contents, target groups)
• Planning and documentation of training
• Documentation
• Structure of documentation
• Responsibilities for the documentation
• SOP
• Documentation in the manufacturing process
• Documentation in the quality control
• Batch record Review
• Questions & Answers

 

Break (1200-1215)

 

Session 2 (1215-1515) 

• Annual report / Product quality Report
• Specifications
• Premises / Production
• Requirements for room and equipment
• Classification of rooms
• Sterile production/Isolator
• Maintenance of hygiene
• How to behave during production
• Quality Management System (QMS) cited in the regulations
• How to implement and structure a quality system
• Responsibilities
• Deviations
• CAPA
• Change Control
• OOS
• Questions & Answers

 

Day 2

 

Session 1 (0900-1200)

• Failure Investigations
• Self-inspections
• Risk Management
• Main topics of ICH Q 9 / Part 3 EU GMP Guideline
• Use of risk analysis during qualification
• How to handle FMEA?
• Qualification/Calibration/Maintenance
• Organizing qualification
• Steps in Qualification studies: DQ, IQ, OQ, PQ
• Qualification parameters of typical types of equipment: Clean rooms, water systems, production equipment, analytical equipment
• Performing risk analysis: tools and practical tips
• Calibration: critical types of equipment
• How to build up a calibration system
• Maintenance: Requirements and System
• Questions & Answers

 

Break (1200-1215)

 

Session 2 (1215-1515)

• Validation
• Process Validation
• PAT
• Validation Master Plan (VMP)
• Cleaning Validation
• Computer Validation
• Validation of Analytical Methods
• Audits and Self-Inspections
• Packaging/Storage/Transportation
• WHO good storage practice – elements and requirements
• Transportation as part of storage
• How to maintain the quality during Transportation
• Falsified Products
• Responsibilities of QP and the pharmaceutical industry
• Questions & Answers