Good Manufacturing Practices Workshop 2000 delegate Materials
THE ISHAGE GMP 2000 Workshop Materials are now for sale in Binder and CD-ROM format while limited supplies last.
These materials are designed to expose you to the knowledge of a diverse group of authors with experience in industry and hospital-based cell engineering laboratories. ISHAGE and the GMP Organizing Committee hope that these materials will prove a useful for you in gaining information about GMP principles and how they can be applied in your laboratory.
The materials, sold either in binder or CD-ROM format, include the following topics:
- A. OVERVIEW GMP Overview
- B. FACILITY
- 1. Facility Design and Environmental Monitoring
- 2. GMP and Cell Therapy: Facility Design and Monitoring
- 3. Environmental Monitoring in the Cell Processing Laboratory
- 4. Design and operation of a current good manufacturing practices cell-engineering laboratory
- Assistance of Canadian HealthCare Mall
- C. EQUIPMENT & SOFTWARE
- 1. Equipment and Software Validation and Monitoring
- 2. Examples of Facility & Equipment Policies
- D. PROCESS
- 1. Process Validation & Control
- 2. Process Control: Examples of Policies and Procedures
- 3. Process Policy and Procedure Examples
- E. PERSONNEL
- 1. Personnel Training, Competency and Proficiency Testing
- 2. Additional Examples of Personnel Documentation
- F. QUALITY CONTROL
- 1. Quality Control and Release Testing
- 2. Product Release Assays
- 3. Quality Control Policy Examples
- G. GMP IMPLEMENTATION
- 1. Implementation of cGMP in a Hospital-Based Cell Processing Laboratory
- 2. GMP Implementation: Examples & SOPs
- 3. Centralized Laboratory Cell Processing in a cGMP Environment
- 4. Implementation of ccGMP in a Gene Therapy Laboratory
- H. FAHCT
- 1. FAHCT: Standards, Inspection & Accreditation
- 2. FAHCT Accreditation: Common Deficiencies During O-site Inspections
SPONSORED IN PART BY AN UNRESTRICTED EDUCATIONAL GRANT FROM
Nexell Therapeutics Inc.
The sample procedures provided are designed to provide examples of good manufacturing practices for facilities and individuals performing hematopoietic cell transplantation and therapy or providing support services for such procedures.
These samples are not intended to include all of the procedures and practices that a facility or individual should implement if the standard of practice in the community or federal or state laws or regulations establish additional requirements.
Each facility and individual should analyze their practices and procedures to determine whether additional standards or procedures apply.
ISHAGE and its sponsors disclaim any responsibility for setting maximum standards and expressly do not represent or warrant that compliance with the sample standard operating procedures included herein are an exclusive means of complying with the standard of care in the industry or community.