Microbiological Contamination Control & GMP for Cosmetics, Personal Care and Pharmaceutical Industries

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1 2018 Attend and receive a copy of Pharmigs Guide to Bacterial Identification Supported by the Venue: Lea Marston Hotel Haunch Lane, Lea Marston Sutton Coldfield Warwickshire B76 0BY Early Bird Offer Send 2 people and the 2nd attendee receives a 25% discount. Limited places available until 16th March 2018 Date: 19th April 2018 For more information contact T: + 44 (0) F: +44 (0) E: info@pharmig.org.uk W:

2 Hear from leading industry experts: Amanda Isom Technical Affairs Manager CTPA Kevin Wright Principle Scientist P&G Kirsty Hutchison Business Improvement Programmes Director Smallpeice Enterprises Ltd Phil Greaves Consultant Biotiq Tony Mayhall MD MQA Solutions Andy Brack Technical Services Executive/ Principal Microbiologist PZ Cussons (UK) Ltd David Keen Senior Global Microbiology Consultant Ecolab & Pharmig Chair Peter Jay Expertise Team Leader: Preservation and Applied Microbiology Unilever Eshwar Mahenthiralingam Professor of Microbiology Cardiff University Professor Andrew McBain Senior Lecturer University of Manchester Who should attend: Microbiologists Hygiene Specialists Technical & R&D Quality Assurance Engineering Production & Manufacturing Quality Control Formulation Chemists

3 Thursday 19th April 2018 Conference Programme Programme outline for the day Morning sessions address general topical issues that will be of interest to all attendees Afternoon sessions are divided into 2 streams: R&D Microbiology and Factory and Laboratory QC Microbiology. Please tick which stream you would like to attend on your booking form Registration Welcome from the Chair Phil Greaves - Director, Biotiq Consulting Cosmetic GMP - Typical audit findings and how to prevent them Audits against Cosmetic GMP standards ISO surprisingly identify common recurring deficiencies. Understanding what these are and their repeating nature will reduce the risk of findings impacting your company. Tony Mayhall MD, MQA Solutions Burkholderia: remarkably resistance, persistent and multifaceted microorganisms Challenges around the organism Best practice for prevention and eradication Eshwar Mahenthiralingam PhD, Professor of Molecular Microbiology, Microbiomes, Microbes & Informatics Group, Organisms & Environment Division School of Biosciences, Cardiff University Biofilms: They are here to stay: But how can we manage them? Biofilms are the common survival form for microbes in the environment, providing protection and co-nutrition under hostile conditions. While this is beneficial in the environment, in manufacturing its presence can result in significant, recurring quality problems. This talk will provide an introduction and focus on a primary raw material - water- and the characterisation, monitoring and control of biofilms in a manufacturing system. Kevin Wright Principle Scientist, P&G Morning break 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 Phil Greaves Director, Biotiq Consulting Root cause analysis for microbiologists: An interactive multimedia Root Cause Analysis case study Problem solving is a fundamental skill for scientists and those with responsibility for process improvement and yet teams often fail to find and permanently address the true root cause of issues. In this interactive and entertaining session, learn about the cognitive biases that can cause barriers to problem solving and learn through practical application some powerful root cause analysis tools that help to eliminate these. Kirsty Hutchison Business Improvement Programmes Director, Smallpeice Enterprises Ltd Lunch Afternoon Streamed Sessions (please refer to page 4)

4 Thursday 19th April 2018 Conference Programme (Please tick on your booking form which stream you wish to attend) Session Session Session STREAM 1 R&D Microbiology Preservative Efficacy Testing (PET) (ISO, EP, USP, BP, KOKO) standard/merits Introductory overview of PET and antimicrobial efficacy methods What are the high risk organisms? Are there any new offenders being recovered? This session is a combination of a lecture led overview followed by a group discussion. The aim being to develop a best practice harmonised method Peter Jay Unilever Supported by: Phil Greaves Biotiq Consulting & Andy Brack PZ Cussons & Pharmig Committee Member Preservatives: Cosmetics regulation update Current status of Annex V Regulatory timescales Claims to include: free from claims CTPA position on microbiome claims in relation to cosmetics Amanda Isom Technical Affairs & Digital Manager, CTPA (Cosmetic, Toiletry & Perfumery Association) Afternoon Break The human microbiome: Opportunities & challenges in health & cosmetic claims Introduction including a look at which of the older methods still work! The skin microbiome in health and disease (an outline) and other microbiotas Advantages and challenges of NGS approaches Professor Andrew McBain Senior Lecturer, University of Manchester STREAM 2 Factory and Laboratory QC Microbiology Making microbiology visual Communicating microbiology to the factory How do we get production operators involved and engaged? Microbiome- QC- education for line/production crews in microbiology. Communicating the risks to production and consumer Tony Mayhall MD, MQA Solutions Case study for QC microbiologist/non steriles: Dealing with microbial contamination in your water systems Advice and action for the factory QC discussion group: as a microbiologist what is your recommendation to the business? Summary of discussion outcomes David Keen Senior Global Microbiology Consultant, Ecolab & Pharmig Chair Afternoon Break Which microbial identification system is best for you? A summary of different identification systems available Key considerations in choosing a system appropriate for the facility and / or product type The importance of understanding your facilities requirements and developing a user requirements specification David Keen Senior Global Microbiology Consultant, Ecolab & Pharmig Chair Close out by Phil Greaves Biotiq Consulting Close out by David Keen Pharmig Chairman Please note: all information addressed by the speakers are of their own / company opinions. Pharmig is not responsible for any content presented at the meeting. Pharmig also has the right to change the programme at any time due to unforeseen circumstances.

5 Registration Form Please reserve place(s) for the Pharmig conference: & GMP for Cosmetics, Personal Care and EARLY BIRD OFFER ends Friday 16th March 2018 Send 2 people from the same company (booking at the same time) and the 2nd receives a 25% discount to attend Company: Address: Tel: Fax: MAIN CONTACT (IF DIFFERENT FROM DELEGATES ATTENDING THE CONFERENCE) First Name: Surname: Tel: DELEGATE ONE Name: Surname: Job Title: STREAMED AFTERNOON SESSIONS Please tick which stream you would like to attend R&D Micro Stream Factory and Lab Micro Stream Please state any specific dietary requirements DELEGATE TWO Name: Surname: Job Title: STREAMED AFTERNOON SESSIONS Please tick which stream you would like to attend R&D Micro Stream Factory and Lab Micro Stream Please state any specific dietary requirements (Send 2 people and the second receives a 25% discount to attend offer ends Friday 16th March 2018) 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) For more information contact T: + 44 (0) F: +44 (0) E: info@pharmig.org.uk W:

6 Conference Fees Conference fees are detailed below and include: lunch/ refreshments on the day and a link to download Conference presentations in advance of the meeting. Pharmig has gone green and no longer produces printed documentation folders. Conference fees do not include accommodation, which must be booked and paid for directly with the hotel. NB: Fees must be paid by Friday April 6th 2018 in order to guarantee a place(s) at the Conference. Pharmig & CTPA Member Fees Delegate 425 / 500 Bed & Breakfast 89 Pharmig & CTPA Non Member Fees Delegate 525 / 610 Bed & Breakfast 89 * Euro fee is higher to cover conversion rates NB: Discounted rates are available for non-profit making organisations and charities. Hotel Lea Martson Hotel, Haunch Lane, Lea Marston, Sutton Coldfield, Warwickshire, B76 0BY A reduced rate of 89. has been secured with the hotel. If you require a room for the night of the 18th April please call the hotel directly stating you are booking onto the Pharmig meeting to ensure you receive the reduced rate. Reservations Contact Details: Telephone: +44 (0) reservations@leamarstonhotel.co.uk Location: Lea Marston Hotel is situated close to the Midlands transport network and Birmingham airport Publications Pharmig s latest guide looks at bacterial identification, presenting standard techniques in full detail for new starters and trainees, and the latest phenotypic and genotypic test systems including guidance on how to select the best system. Also featured in the publication is an approach to identification strategy, discussing the common issues faced by microbiologists as to what to identify, when, and how often. Also available to purchase as a PDF Rapid Microbiological Method technologies aim to provide more sensitive, accurate, precise and reproducible test results when compared with conventional, growth-based methods. They normally involve some form of automation and they often capture data electronically. This document has been prepared: These topics are discussed clearly and in detail, alongside illustrations, photographs and references. Whether you are new to bacterial identification or an experienced practitioner, the Pharmig guide has something to offer and has its place alongside your identification bench. The guide and it has been written by experienced practitioners Dr. Anna Lovatt and Dr. Tim Sandle. to describe the range of well developed, established, commercially available methods and their suitability for evaluating the microbiological quality of products or raw materials; to provide some guidance for microbiologists who are investigating the use of R/AMM in routine quality control of cosmetics personal care products and pharmaceuticals. Member 40 Non Member 60 Please visit the pharmig website for more details and a full list of Pharmig publcations For more information contact T: + 44 (0) F: +44 (0) E: info@pharmig.org.uk W: