Compliance for Biopharmaceutical
API Process Validation

Industry field:

Biopharmaceutical industry

Course description:

With the issuance of ICH Q8, Q9, Q10 and the new draft FDA Guidance on Process Validation, firms involved in biopharmaceutical/biologic manufacturing are likely to face increased regulatory scrutiny. Even firms with approved products will be expected to understand the concepts of Quality by Design (QbD) and have documented a process control strategy regardless of their initial validation efforts. This course reviews and interprets the current regulatory requirements and expectations including, provides examples, overviews documentation, and discusses current industry trends.

Historically, biopharmaceuticals/biologics products have always faced special requirements in the validation of their processes. FDA and other regulatory agencies have long been aware of the extent to which the “process defines the product” in this field. A rational approach that incorporates the concepts of quality systems and risk management is presented to include consideration for Process Validation during all stages of development through and beyond product approval. Special emphasis is given to parameter selection and evaluation including determination of criticality and setting of valid ranges/limits. Critical elements of specific studies required for biopharmaceuticals/biologics will be reviewed such as chromatography resin lifetime .

Course outline:

• Introduction: Regulatory Requirements and Compliance Overview

• Process Validation Support Studies

• Building in Quality: Lab Bench to Market Production

» Click here for detailed course outline

Learning objectives:

This course is designed to provide a basic overview of issues and compliance requirements specific to validating a biopharmaceutical/biologic manufacturing process. Attendees will learn critical elements for review and/or inclusion in the Process Validation program and associated documentation.

Who should attend:

Personnel in Development, Manufacturing, Validation, QA, and QC involved in process validation and process control should attend. Course assumes the attendee has a basic understanding of the GMP regulations.

Course facts

Do you want our newsletter?

» Make sure to get the latest information

» Tip a colleague