Biopharmaceutical Courses

 
Course:
Principles of Project Management for
Biotechnology

ID#
BP-0001

Series Type:
Course

Intended Audience:
Biologist with non-agriculture educational background

Scope:
To gain knowledge in concepts helpful in the type of work either lab or field work of seeds companies.

Description:
This one day seminar is an introduction to project management principles. It provides an overview of key project concepts and terminology to help individuals effectively initiate, plan, execute, monitor & control and close a project. It will discuss the project management framework as described by PMI and emphasizes in understand and apply the best practices and tools related to project management to biotechnology industry.Individual who will benefit from this seminar include team leaders and team member assigned to a project team, student and all professional seeking to improve their project management skill and knowledge. Attendees will learn the fundamentals, tools, and concept of project management and apply them to the biotechnology industry.

 

Course:
QC Microbiology Overview

ID#
BP-0002

Series Type:
Course

Intended Audience:
Biologist with non-agriculture educational background

Scope:
To gain knowledge in concepts helpful in the type of work either lab or field work of seeds companies.

Description:
This one day seminar provides a overview of Quality Control (QC) Microbiology as is practiced in the biopharmaceutical and medical device industries with the emphasis on manufacturing practices. Attendees will acquire the basic knowledge in microbiology and be familiar with typical microbiological tests in the Pharmaceutical Industry. It provides a brief discussion of what is microbiology, quality systems within the microbiology laboratory, and the microbiology best practices.Attendees will learn about the main regulations impacting microbiology within a manufacturing environment and the basis of working in a regulated environment. The seminar will provide an introduction to the manufacturing process, quality systems, FDA regulation, compliance aspects like change control, investigations, corrective and preventive actions (CAPA), deviations and non-conformances, validation, and quality audits.This seminar is useful to people who want to acquire or refresh their knowledge in microbiology as applicable to a manufacturing industry. Also, students and individuals with no previous experience in QC Microbiology and who are exploring to be employed within a manufacturing industry will benefit this seminar.

 

Course:
Process Validation for the Pharmaceutical
and Medical device Industries

ID#
BP-0003

Series Type:
Course

Intended Audience:
Participants are invited to bring examples of own validation issues to be discussed during the case studies session

Scope:
To gain knowledge in concepts helpful in the type of work either lab or field work of seeds companies.

Description:
Validation of manufacturing processes in the cGMP en environment and by the regulatory agencies in the U.S., E.U. and Japan. This course will give the attendee an overview and understanding of the validation process, how to organize it and carry out process validations, key areas to look for during an audit, and assist managers in overall planning.Various approaches to validation will be discussed with actual examples of successes and failures of industry validation experiences.