Pharmig’s 30th Anniversary Conference – Nottingham (NHS)

£550.00 (Member price £400.00 - Join Now)

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Pharmig’s 30th Anniversary Conference – Nottingham (NHS)

30th November & 1st December

Member Fee £400 (Join Now) / Non-Member Fee £550

Confirmed Topics & Speakers

Note: Titles and bullet points will be more detailed as speakers send outlines for the full conference agenda

1. Key Note Session: Annex 1 overview and Contamination Control Strategies (CCS) drawing on sterile & non sterile impacts
Phil Rose – Executive Director, NSF International (ex-MHRA)

2. ID Strategies
Kevin Wright – Director Corporate Quality Assurance – Industrial Microbiology, Procter & Gamble

3. DEBATE – BCC testing is here to stay – the new sterility test! Pistols at dawn debate of the year.

Burkholderia Cepaciea Complex testing is here to stay – will it become another pointless sterility test?

Should the approach to BCC be based on risk and a scientifically justified approach or, following a poor track record of compliance by industry, should a blanket test approach be put in place? The industry cannot be trusted to police itself, here comes the non-sterile products sterility test!

FOR: Edel Fitzmaurice – Quality Director/QP, Fitzmaurice Scientific Ltd
Will argue that more mandatory testing is needed. Why can’t industry be trusted to self-police? How many inspection findings of companies failing to protect patients against BCC will it take? Test now, talk later!

AGAINST: David Keen – Director Pharmaceutical Microbiology, Ecolab
Will argue for a risk-based approach. Regulators should just allow industry to follow the bleedin science! Why should good sites and companies be punished by the lack of action and understanding of others? Quality departments should listen to microbiologists and not run in fear from the regulators.

4. Situations where cleaning & disinfection is not that straightforward, or has some special considerations Examples:
A) ATMPs – using data on H202 disinfectants on cell cultures
Seb Hodgkin – Senior Director, Quality Assurance, Quell Therapeutics

5. “Where did they come from? Considerations for test strains”

  • Background to taxonomy & factors for microbial ID
  • Review of compendial test strains & their origins
  • Comparison of genotypic and phenotypic attributes of culture collection strains
  • Application of test strains in the pharmaceutical micro lab

Miriam Guest – Principal Microbiologist, AstraZeneca & Speaker TBC

DRAFT TOPICS:

Where speakers have been invited & not confirmed to date. These topics may change for the final confirmed agenda

  1. FDA’s expectations around Burkholderia cepacia – FDA invited
  2. Implementing new and innovative microbiological control strategies for the manufacturing of sterile and non-sterile drug products – Novartis invited
  3. Insights into the risks and risk reductions with bacterial endotoxin – JNJ invited
  4. Vendor control of sterilisation – Baxter invited
  5. Data Integrity and microbiology – Novartis invited
  6. How to stop fungi getting into your cleanroom – covering sterile and non steriles
  7. Transformational technologies: Artificial intelligence for quality control in practice

Click here to download Advance Notice with Confirmed Presentations and Booking Form – 30th Annual Conference 30th Nov – 1st Dec

Additional information

Date