Current Hot Topics in Pharmaceutical Microbiology Tuesday 23rd May 2017

Transcription

1 Presents Current Hot Topics in Pharmaceutical Microbiology Tuesday 23rd May 2017 Best Practices in Environmental Monitoring: Covering Steriles & Non-Steriles Wednesday 24th May 2017 Leading experts include: Dearbhla Cullen, HPRA Kevin O Sullivan, Irish Times Tim Sandle C, BPL Hans Noordergraaf, Abbott Biologicals Seb Hodgkin, Cell Medica Patrick Nieuwenhuizen, Genzyme a Sanofi Company Phil Greaves, Biotiq Consulting Sinead Cowman, Lonza Rachel Blount C, Ecolab Edel Fitzmaurice C, Fitzmaurice Scientific Ltd Richard Fitzpatrick, Boston Scientific Claire Doyle, Pfizer Jane Wyatt, Alexion Pharmaceuticals Discounts apply for each event and for those wanting to attend both OFFERS END 21ST APRIL 2017 (see booking form for further information) Venue: Portmarnock Hotel & Golf Links, Co. Dublin Pharmig T5 The Maltings, Roydon Road, Stanstead Abbotts, Hertfordshire, SG12 8HG, United Kingdom. Tel: +44 (0) Fax: +44 (0) info@pharmig.org.uk Web:

2 Hot Topics In Pharmaceutical Microbiology Tuesday 23rd May 2017 Portmarnock Hotel, Dublin Sending 2 people and book before the 21st April the 2nd person receives a discount on advertised fees Registration Chairs Welcome Rachel Blount C Global Validation Manager, Ecolab & Edel Fitzmaurice C Quality Director, Fitzmaurice Scientific Ltd Introduction and Setting the Scene Kevin O Sullivan - Editor, Irish Times Key Note Session: Regulatory Requirements for Contamination Control Strategies What are regulators looking for in documents supporting a site contamination strategy? How do investigations impact on a contamination control strategy? Annex 1 update what changes are required from a contamination control perspective? Case studies of deficiencies issued in relation to contamination control strategies? Dearbhla Cullen GMP Inspector, HPRA Practical Aspects of Pharmaceutical Microbiology From QC analyst to Microbiologist Steriles v non-steriles Contamination controls Patrick Nieuwenhuizen Manager Quality Control, Genzyme a Sanofi Company Meet & Greet the Exhibitors with Tea/Coffee Investigation of a UK Recall Due to Microbiological Contamination History of the contamination event The implications of changing the preservative system Limitations of preservative challenge testing Manufacturing process investigation and risks Root cause and remediation An approach to LER (Low Endotoxin Recovery) & Update of EP chapter Hans Noordergraaf - Microbiological Expert, Abbott Biologicals B.V Microbiological Challenges in the Manufacturing of Personalised Advanced Therapeutic Medicinal Products (ATMPs) Overview of personalised cellular therapies/atmp s and their manufacture Key differences and challenges in their manufacture vs traditional sterile products Microbial control strategies Microbiological testing of cellular products Seb Hodgkin- Senior Director Quality, Cell Medica Buffet Lunch in Exhibition Area Open Discussion Sessions Open Discussion Sessions Continued Tea/Coffee in the Exhibition Area Reducing Environmental Monitoring Excursions in a Manufacturing Area Setting the scene: Improving operator behaviours Setting the standard: EM walk-throughs Support and Sustain: The role of the EM Champion Claire Doyle QC Supervisor, Pfizer Microbial Contamination in Aseptic Manufacturing Environments The importance of the control of microbial contamination in aseptic manufacturing environments An analysis of the recent PDA Technical Report 70, Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities Regulatory expectations to provide assurances of appropriate microbial contamination control Jane Wyatt Global Microbiology Leader, Alexion Pharmaceuticals Summary and Close of Conference 2 Hot Topics In Pharmaceutical Microbiology - Tuesday 23rd May

3 Open Discussion Sessions Tuesday 23rd May 2017 Please choose 2 out of the 3 listed and mark accordingly on your booking form. Session 1 Session 2 Session 3 Annex 1 Discussion Session Led by: Phil Greaves - Director, Biotiq Consulting Disinfectant Efficacy Testing Discussion Session Led by: Pharmig Committee Pharmaceutical Microbiology Surgery including an approach to LER Led by: Patrick Nieuwenhuizen Manager Quality Control, Genzyme a Sanofi Company and Hans Noordergraaf - Microbiological Expert, Abbott Biologics B.V. Date For Your Diary Pharmig will be celebrating its 25th ANNUAL CONFERENCE on the 29th & 30th November 2017! VENUE: Crowne Plaza Heythrop Resort, Chipping Norton, Oxfordshire We will be looking to pull out all the stops for this event so do keep an eye out for updates on the Pharmig website Plus... Keep an eye out for Pharmigs exciting launch of its latest product - an on-line interactive training module based around: Cleanroom contamination, Disinfectants (selection, storage and use of) and, Cleaning techniques.. More will be details will be provided at the Conference and please do contact the Pharmig office if you are interested in finding out further information at - info@pharmig.org.uk Hot Topics In Pharmaceutical Microbiology - Tuesday 23rd May 3

4 Best Practices in Environmental Monitoring: Covering Steriles & Non-Steriles Wednesday 24th May Registration with Tea/Coffee Chairs Introduction Tim Sandle C Head of Microbiology, BPL Overview of Relevant Regulatory Guidelines and USP Changes USP <1116> and <1115> Regulations relating to environmental monitoring Key GMP points Main aspects of USP <1116> How does USP <1116> differ from EU GMP and what should you do about is? Tim Sandle C Head of Microbiology, BPL An Overview of the Environmental Monitoring (EM) Strategy Using a risk based approach to get the best out of your EM program EM locations, sorting the pointless from the value adding Which EM locations and what technique to use for them Edel Fitzmaurice C - Managing Director, Fitzmaurice Scientific Ltd Morning Break with the Exhibitors Environmental Monitoring: Incubation Strategies What is environmental monitoring trying to do? Which agar should you select? Should one or two agars be used? Which is the optimal temperature? For how long should you incubate for? What types of microorganisms can you expect to detect? Tim Sandle C - Head of Microbiology, BPL Buffet Lunch in the Exhibition Area ATTEND & RECEIVE A FREE COPY of Pharmigs - Environmental Monitoring Review Publication Environmental Monitoring Identification (ID) Strategy Interpretation of FDA Aseptic Guidance and EU Annex 1 How to manage ID for non-sterile EM How many colonies to identify? How far to go: morphologically, photographic library, biochemical analysis? Patrick Niewenhuizen - Manager Quality Control, Genzyme a Sanofi Company Investigations and CAPA for Environmental Out of Specs (OOS) Telling the whole story Richard Fitzpatrick Senior Site Microbiologist, Boston Scientific Afternoon Break with the Exhibitors Data integrity and beyond: Practical Approaches to Enhance Data Integrity and Regulatory Compliance People, management and mind-set Systems and processes Data lifecycle & data governance Sinead Cowman European Business Development Manager, Lonza Q&A Discussion Session with Presenters How should we go about setting alert and action limits for environmental monitoring? Closing Remarks C Pharmig Committee Member 4 Best Practices in Environmental Monitoring - Wednesday 24th May

5 Booking Form and Hotel Information Please circle the relevant meeting fee (s) outlined in Booking Form A, B or C below BOOKING FORM A Hot topics in Pharmaceutical Microbiology Tuesday 23rd May 2017 Member Fees Non Member Fees 1st Member / 495 1st Non Member / 695 2nd Member / 395 2nd Non Member - 700/ 595 Send 2 or more people from the same company and receive a discount on the full price as outlined above Discussion Sessions - please tick 2 out of the 3 topics listed below: Session 1 Annex 1 Session 2 Disinfectant Efficacy Testing Session 3 Pharma Micro Surgery Please tick which 2 sessions you would like to attend 1st Delegate nd Delegate HURRY! DISCOUNTED OFFERS END 21 ST APRIL 2017 BOOKING FORM B Best Practices in Environmental Monitoring Wednesday 24th May 2017 Attend & receive a free copy of Current perspectives on Environmental Monitoring Review #1 Member Fees Non Member Fees 1st Member / 425 1st Non Member - 736/ 625 2nd Member / 325 2nd Non Member / 525 Send 2 or more people from the same company and receive a discount on the full price as outlined above BOOKING FORM C BOOKING BOTH the One-Day Conference & Best Practices in Environmental Monitoring 23rd & 24th May 2017 If you wish to attend both meetings further discounted fees are as follows: Member Fees Non Member Fees 1st Member - 960/ 820 1st Non Member / nd Member - 731/ 620 2nd Non Member / 1020 NOTE: *Euro fee is higher to cover conversion rates 1st Delegate First Name: Surname: Job Title: Company Name: Address: 2nd Delegate First Name: Surname: Job Title: Company Name: Address: Dietary Requirements: Dietary Requirements: or fax your completed booking form for a confirmed place: info@pharmig.org.uk Fax: to +44 (0) Cheque for sterling / euro to cover delegate fee(s) enclosed Cheque for sterling / euro to follow Total of sterling / euro transferred electronically Please supply invoice F.A.O.: Please quote purchase order number: I wish to pay by credit card (Pharmig will contact you for details) Booking Form and Hotel Information 5

6 Hotel Information Note: Fees must be paid by Friday 5th May 2017 in order to guarantee a place(s) at the Conference or one-day meeting Note: Fees for both meetings include lunch, refreshments and links will be sent in advance to download relevant presentations. (Pharmig has gone green and will no longer be providing printed documentation folders). Fees do not include accommodation, which must be booked and paid for directly with the hotel. THE VENUE: Portmarnock Hotel & Golf Links is just 15 minutes from Dublin airport and less than 25 minutes from the city centre. The hotel has full conference facilities with accommodation, dining choices and spa area. ACCOMMODATION: A limited number of bedrooms have been reserved at a special rate of 135 for overnight delegates (please book early to avoid disappointment). Rooms need to be booked directly with the hotel. Please call The Portmarnock Hotel & Golf Links on (0) and quote Pharmig to ensure you receive the discounted rate. GOLF: For those wishing to play golf a green fee rate of 70 is available for those staying at the hotel. Please call +353 (0) to book. ADDRESS: Portmarnock Hotel & Golf Links, Strand Road, Portmarnock, Co. Dublin, Ireland CANCELLATION POLICY: Written cancellation will be accepted up to 30 days prior to the event, and all cancellations will incur a fee. No refunds are available 15 working days before the start date and full course fees will be due for delegates who fail to attend. Substitutions may be made at any time, preferably in writing to Maxine Moorey. Please send to: Maxine Moorey, Pharmig, T5 The Maltings, Roydon Road, Stanstead Abbotts, Hertfordshire, SG12 8HG or by maxine@pharmig.org.uk Please note Pharmig reserves the right to alter the programme in the event of unforeseen circumstances. Please note that the views expressed by individual contributors are their own and do not necessarily reflect the views of Pharmig as a whole. Pharmig T5 The Maltings, Roydon Road, Stanstead Abbotts, Hertfordshire, SG12 8HG, United Kingdom. Tel: +44 (0) Fax: +44 (0) info@pharmig.org.uk Web: