ALFRED CAMPOS CAPSIG NSW Committee Member
EMMETT BRODERICK GMP Inspector, Therapeutic Goods Administration
WYLIE ARMSTRONG Customer Support Manager Industrial Microbiology, bioMérieux
GEORGIA CRITCHLOW Senior Quality Control Specialist, AstraZeneca
Environmental Monitoring (EM) in pharmaceutical manufacturing (sterile and non-sterile) is a risk-based microbiological and particulate control program that form part of the CCS and is designed to monitor and demonstrate that cleanrooms, personnel, equipment and manufacturing processes remain in a validated state of control. It provides ongoing data to assess environmental conditions, detect adverse trends and ensure that product quality and patient safety are maintained. A well-designed EM program is risk-based, with sampling locations, frequencies, methods and limits justified by cleanroom classification, process criticality, airflow patterns, personnel activity and historical data. While individual EM results do provide a snapshot in time, analysing trends periodically (whether weekly, monthly, quarterly) does identify early warning signs that could signify issues such as, but not limited to, poor HVAC performance, poor cleaning effectiveness, poor gowning practices. Essentially, trending supports a proactive contamination control, enabling timely investigation, corrective and preventive actions (CAPA), and continuous improvement. This seminar brings together regulatory, sterile manufacturing and monitoring solutions supplier and we explore different ways to trend using computerised systems specifically available for environmental monitoring, and we will inform the regulatory expectations to help build your robust environmental monitoring program.
The Lounge, Level 2Wests Ashfield Leagues Club115 Liverpool Rd, Ashfield NSW 2131
PLEASE NOTE: CAPSIG NSW CANNOT ACCEPT ONLINE PAYMENT TRANSACTIONS AT PRESENT. SUBMITING THIS FORM IS FOR REGISTRATION PURPOSES ONLY.
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DIRECT DEPOSIT PREFERRED TO: Account Name: CAPSIG NSWAccount No. 043 238 414BSB: 112-879Bank: St George ALTERNATIVELY CHEQUES & PRINTED BOOKING FORM SEND TO:Ms Melissa BOURKEPO Box 432, Alexandria NSW 1435 ALL ENQUIRIES EMAIL:
melissa.bourke@biomerieux.com
1. Registration and Payment must be made by the Seminar RSVP Date2. Payment must be by direct deposit or cheque (include your company/name in the transaction details)3. All cheques must be made out to: CAPSIG NSW4. Any Cancellations must be made prior to the Seminar RSVP Date, otherwise full cost of the Seminar must be paid5. CAPSIG NSW is a non-profit group with an annual turn-over less than the statutory limit and hence GST is not applicable or charged6. If you require an invoice, please email:
Event 3Date: TBA
Event 1Date: TBA
