Auditing Analytical Laboratories for FDA Compliance
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Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.
Areas Covered in the Session:
Who Will Benefit:This webinar will be of benefit to company auditors who need to investigate the qualifications of contract testing laboratories and internal testing facilities. It will also be beneficial to workers in laboratories that will be audited or inspected by external parties. Personnel from companies that perform testing on small molecule drugs, biologicals, and nutraceuticals will benefit from knowing what standards are being applied to them.
- GMP regulations that apply to analytical laboratories
- Reviewing documentation
- Advance preparation for the audit
- Auditing styles and structures
- Equipment and laboratory instrument qualification
- What to look for while doing a walk-through
- Other regulations and standards, including ISO 17025
- Following through on the audit
The following specific types of workers will benefit from this webinar:
- External and Internal Auditors
- Supervisors and Analysts in Quality Control Laboratories and Quality Assurance groups
- Supervisors and Analysts in Contract Testing Laboratories
- Personnel Responsible for Selecting Contract Testing Laboratories
Steven S. Kuwahara , Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steven has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steven has participated in the development of drugs and biologicals through all phases of clinical research and final product production.