QA and QC Compliance Strategies for Biopharmaceuticals

Biotechnology products are intended to be produced under cGMP conditions with the support of a reliable and credible quality system. In order to generate, then verify, sound scientific and operational practices, the quality system should comprise prospective elements of Quality by Design as well as retrospective elements of review and inspection. This course will present critical factors to consider in establishing, maintaining and/or remediating appropriate compliance strategies in the production and testing of biopharmaceutical products. Current ICH documents defining requirements for quality assurance throughout the product lifecycle will be reviewed.

Practical examples will be presented based on the extensive technical, regulatory and quality expertise of the course instructors from their combined experiences in regulatory agencies as well as both pharma and contract organisations. Specific QA/QC considerations for biologically-derived products will be discussed.

Apply expert knowledge to ensure QA and QC compliance

By attending this course you will obtain a clear, concise view of the types of QA and QC activities necessary for biologically-based products from preclinical/clinical development to commercialisation. You should be able to identify the major elements of a quality management system applicable to biotechnology production processes and testing laboratories. Practical aspects of quality audits and inspections will be presented to illustrate best practices in biotechnology QA roles and responsibilities. Finally, you will be shown recent warning letters from regulatory inspections to provide a real-world perspective of common deficiencies to be avoided in pharmaceutical production and testing operations.

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