We are almost halfway through 2022 which seems unbelievable! This is a good time to pause and look at the exciting opportunities for our Phamrig members and non-members in respect of the in-person and virtual meetings we have scheduled for the rest of the year, as well as upcoming webinars. As pharmaceutical microbiologists it is critical to develop our practise through engaging with one another as a community to move our discipline forward. Let’s look at the full schedule of upcoming opportunities before celebrating our 30th annual conference in November:
1st June: Approaching error risk reduction: making your labs more compliant (webinar)
8th June: Annual Irish Conference: Hot Topics in Microbiology – Dublin (In person)
9th June: Cleaning & Disinfection: a roadmap to compliance – Dublin (In person)
29th June: Designing an effective contamination control strategy (½ day virtual)
21-22nd Sept: Basic Microbiology Skills- Practical Training Course (In person)
WEBINARS
1st June:
Approaching error risk reduction: making your labs more compliant
It is well established that regulators do not like the root causes of deviations to conclude ‘human error’ and for the resultant corrective or preventative action (CAPA) to recommend additional training. Instead, regulators expect organizations to go deeper and to unpick the underlying reasons as to why a person made an error and, from this, error risk reduction actions can be initiated.
- This webinar looks at:
- The ‘what’ and ‘why’ of human error
- The ‘true’ causes of error
- Chunking and subchunking tasks
- Developing human error checklists
- Root cause analysis
- Trending error
HYBRID: IN PERSON AND VIRTUAL MEETINGS
Annual Irish Conference – Hot Topics in Microbiology – Dublin
Topics covered include:
- Objectionable organisms
- Recent recalls across the pharmaceutical and healthcare industries, highlighting key trends and the impact such incidents have.
- Recent developments with the growth promotion test and environmental monitoring
Cleaning and disinfection: road map to compliance
Topics covered include:
- Upcoming regulatory changes and their impact for cleaning & disinfection: EudraLex draft Annex 1 v.12 & USP draft chapter
- Brief summary of the history of these publications and their revisions to date
- Key changes in the proposed draft regulations relating to cleaning and disinfection, versus current industry practice
- Disinfectant Workshop: Factors to consider when designing a disinfectant efficacy test and interpretation of results
VIRTUAL MEETINGS
Designing an effective contamination control strategy
Topics covered include:
- Regulatory expectations around contamination control strategies
- What do you actually need to think about when setting up your CCS?
- Case study 1 – Astra Zeneca: A practical approach on how they set up a CCS (Sterile)
- Case study 2 – GlaxoSmithKline: A practical approach on how they set up a CCS (Non-Sterile)
IN PERSON
Basic Microbiology Skills- Practical Training Course
A 2-day course designed for those who are new to pharmaceutical microbiology. Laboratory based with a strong focus on practical techniques, as well as group exercises and lectures. Attendees will have the opportunity to practice fundamental techniques. Course contents include:
culture maintenance, microbial identification, environmental monitoring, aseptic technique, and data integrity for the microbiology lab.
- You will leave this course with a clear understanding of not only what happens in a microbiology lab, but why the tests are performed and how to document them correctly.
- Training in the basics will help you to:
Understand contamination risks to the process
Evaluate the effectiveness of current control measures
Maintain compliance with cGMP and data integrity expectations for the laboratory
A fantastic mix of in person and virtual events that the Pharmig community are proud to offer members and non-members in 2022.
