The course “Inspections and Audits at the Microbiology QC Laboratory” will examine the most relevant aspects and activities of microbiology QC laboratory management, environmental and process monitoring, documentation management and relevant aspects of data integrity highlighting the most critical aspects to consider during inspection visits.
The Microbiology QC laboratory is responsible for many key objectives to ensure patient safety and medicinal product quality. Quality control of materials and finished products, method development, process and product design, monitoring of environments and utilities and product stability are just some of the objectives.
Given the multiplicity and specificity of aspects that are part of the activities of a microbiology laboratory, the knowledge required of the auditor is multifaceted and must include both specific technical knowledge and regulatory skills.
The course will cover a range of cross-cutting content so that it will be useful both for those who need to prepare for an inspection and for those who need to conduct an audit.
The information, details and tools that will be provided by the speaker make the course “Inspections and Audits at the Microbiology QC Laboratory” particularly interesting and stimulating.
Key points of the training
- Understand the main regulatory requirements that underlie the activities of a microbiology laboratory
- Learn the key points subject to audit and inspection
- Effectively deal with a microbiology laboratory inspection
- Understand the requests and expectations of regulatory authorities and potential areas of non-compliance
- Promote continuous improvement of the microbiology laboratory
09:00 – 13:00 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
- Regulatory context and guidelines with particular reference to the requirements of the new Annex 1
- How an AIFA/FDA Inspector prepares for a regulatory inspection
- How to prepare and manage the regulatory inspection
- Microbiological Best Laboratory Practices
- Infrastructure of a microbiological analysis laboratory
- Management of reagents, media and standards
- Microbiological cultures
- Equipment and tools
- Laboratory controls, handling and sample flow
- Methods of analysis and validation
- Records and documentation
- OOS and MDD (microbial data deviation)
- Data integrity in the microbiology laboratory
- Staff training
- Recurring deviations in AIFA and FDA regulatory inspections
Analysts and microbiology laboratory workers, Scientists, Supervisors and Managers of microbiology laboratory, QC and QA, Auditors and inspectors.
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
In order to cancel enrolment to an event, please email firstname.lastname@example.org within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting email@example.com. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Operations Manager Process & Quality
Graduated in 1992 in Pharmaceutical Chemistry and Technology at the University of Siena, she has 30 years of professional experience in pharmaceutical companies and in the world of pharmaceutical consultancy. She began her career in 1992 in the Research and Development of the Technobiochip. Subsequently she worked in Quality Assurance at A. Menarini Industrie Farmaceutiche Riunite (Florence) and in the Corporate Quality Department of the Menarini Group from 1996 to 2000 where she gained experience in the different sectors of Quality Assurance and in Operations. From 2000 to 2009 she worked at Bayer Biologicals (Rosia – SI) where she assumed roles of increasing responsibility up to Plant Manager and Head of Operations. From 2009 to 2011 she was Qualified Person and Plant Manager at Galenica Senese. Since 2012 she has been Operations Manager Process & Quality at Pharma D&S; she is also involved in training activities within Pharma Education Center.
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