4-Hour Virtual Training: Auditing the Microbiology Laboratory

Why Should You Attend:

This 4-hour session (including a midpoint 15-minute bio-break and 15 minutes at the end of the session for Q&A) will focus on the topics a comprehensive microbiology laboratory audit covers as well as how auditors or regulatory agency inspectors obtain evidence (of noncompliance or risk thereof), how they think and the data trails they follow. This knowledge will help you and your company maintain continual improvement of the microbiology laboratory, its facilities, utilities, equipment, documents, records, personnel, and become and remain audit-prepared and audit-friendly.

You should attend this webinar if:

• You are a full-time CGMP compliance/ quality auditor
• You are assisting the regular auditor(s) in auditing your own company or a contract microbiology lab
• You work in the microbiology lab and periodically self-inspect it against CGMPs and SOPs
• You, a microbiology lab supervisor/manager, will host future audits or regulatory agency inspections

Areas Covered in the Webinar:

• Operational definitions
• Audit preparation
• Sampling, sample control, and chain-of-custody
• Document control, record-keeping, and data integrity
• Employee credentials and training
• Contract service providers
• Laboratory controls (i.e., laboratory design/set-up, appearance, environmental controls, ongoing activities)
• Method validation, compendial method suitability testing/verification, method tech transfer, and lab certification
• critical laboratory reagents
• Reference standards microbes, biological indicator spores, and endotoxin
• Equipment, instruments and their qualification, calibration, and maintenance
• Non-sterile product testing for total bioburden, specified as well as objectionable microorganisms
• Sterility testing
• Bacterial endotoxin testing (BET) via LAL
• Virus, mycoplasma, bacteriophage, and other adventitious agent assays
• Water testing (other than BET)
• Contamination control of facilities (specifically sanitization)
• Environmental monitoring, water monitoring, personnel monitoring
• Isolates ID testing and librarying (with cryopreservation)
• Laboratory investigations of microbiological data deviations (MDDs)

Who Will Benefit:

This webinar will provide auditing tools as well as useful compliance knowledge to the following individuals inside and outside the life sciences industries:

• Compliance auditors
• Quality auditors
• Quality control microbiology analysts
• Supervisors, managers, and directors
• Contract lab owners and managers
• Quality assurance and compliance management
• Consultants
• Regulatory agency investigators
• Anyone who wants to gain familiarity with pharmaceutical microbiology

Instructor Profile:

Robert D Seltzer has been president and principal consultant of Worldwide GMP Compliance Professional (WWGMPCP) since 2012, and has been providing/conducting consultancy auditing, QA management, deviation or laboratory or complaint investigations, training in domestic or international pharmaceutical, medical device, food, dietary supplement, or cosmetic Good Manufacturing Practices and related regulations. Mr. Seltzer has 26+ years in life science quality roles after initial 5+ years in R&D/engineering following college and grad school.

He co-championed the ASQ Certified Pharmaceutical GMP Professional (CPGP), adopted by ASQ May 1, 2008. Mr. Seltzer is an ASQ Certified: quality auditor, quality engineer, manager of quality /organizational excellence, biomedical auditor, and pharmaceutical GMP professional (holds certificate No. 1).

He holds an M.S. Biochemistry; B.S., (Bio) Chemical Engineering; and B.A. Biochemistry, all from Rutgers University, New Brunswick, NJ.

Topic Background:

Microbial, endotoxin, exotoxin, viral, or prion contamination of life science products such as finished pharmaceuticals (especially parenterals and biologics), implantable medical devices, foods, and dietary supplements can lead to patient infection, fever, shock, anaphylaxis, and/or death. Therefore, the quality control microbiology laboratory operations, procedures, record-keeping, personnel, reagents, solutions, media, standards/cultures, test methods, instruments, equipment, equipment qualification, calibration and maintenance, laboratory design, lab layout, lab facilities, contracted services, and cognizance of changing regulations, guidances, and compendia must all meet current minimum standards of acceptability as defined ultimately by regulatory agencies (AKA competent authorities in Europe). It is both prudent and expected that internal (or consultant) auditing is performed on the microbiological laboratory(ies) at a frequency that permits coverage of the above topics to assess and help mitigate the risk of false negative, false positive, or other erroneous lab results on finished product, raw materials (excipients or APIs), air, surfaces, formulating and cleaning water.

The auditing skills called upon when assessing a microbiology lab are distinct from the science that underlies Microbiology. In other words, the mindset, background/experience, and intuition of a microbiologist are alone insufficient for performing effective audits of the microbiology lab. Instead, (i) Holistic GMP compliance knowledge and experience, (ii) familiarity with publicized microbiological laboratory failure modes/quality breakdowns, “war stories (e.g., inspection findings),” and (iii) properly comprehensive audit planning and organization are necessary and sufficient for fulfilling the regulatory agencies' expectations of this highly important combination compliance-and-quality audit.

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