Overview of Compliance for Biopharmaceutical Process Validation
Approximate Time: 2 hours
Who Should Attend:
This course is designed to provide a quick overview of compliance
considerations for validating a
biopharmaceutical manufacturing process. Personnel in Development, Manufacturing, Validation, QA,
and QC involved in process validation and process control should
assumes the attendee has a basic understanding of the GMP
manufacturing biotechnology-derived pharmaceuticals face special
requirements in the validation of their processes and rigorous
scrutiny from Regulatory Agencies that are well aware of the
extent to which the process defines the product in this field.
This course reviews and interprets the specific regulatory
requirements, provides examples of the required documentation, and
discusses current industry trends and regulatory hot topics.
mindset is presented to include consideration for Process
Validation in all aspects of manufacturing, including describing
the Quality Assurance role, what must be accomplished as early as
the process development lab bench, compliance considerations for
raw materials, how process tolerances and uncertainties affect
critical parameter ranges, assay issues, scale up issues, and
considerations in technology transfer.
In addition to demonstrating that the process itself is under control, several key additional process characterization studies are required for biopharmaceuticals. Requirements for these are discussed in detail, including genetic stability, DNA and host-cell protein removal, clearance of process additives, viral clearance/inactivation, process pool hold times, buffer hold times, chromatography cleaning, storage and reuse, and membrane cleaning and reuse.
Course Topics include:
NOTE: This course is also available in an expanded 2 day version that covers many more details of the applicable regulations, as well as including many more examples and participant exercises to ensure the material has been assimilated.