THE VOICE OF MICROBIOLOGY FOR 30 YEARS: 1991 - 2021 Is this your first time receiving Pharmig info? Would you like to continue to be updated on our meetings & webinars etc? If yes, please click here An Introduction to to send your details. Sterile Manufacturing WEDNESDAY 21ST & THURSDAY 22ND OF APRIL 2021 A VIRTUAL ZOOM EVENT SPLIT OVER TWO DATES Topics covered include: • Introduction to sterile manufacturing • Process manufacturing • Introduction to microbiology • Sterility assurance • Introduction to cleanrooms • Sterile manufacturing and the regulations and • Methods of sterilisation compliance to GMP Do also take a look at Pharmig current publications outlined on pages 6 - 8 AND our interactive on-line training module on Cleaning & Disinfection of Cleanrooms On page 9 you can view additional upcoming meetings & webinars Pharmig ‘Virtual’ Testimonials: “ Thank you for all the work in preparing the “ Excellent presentations & organisation – really presentations and presenting over the last two enjoyed it” - MML days. It has been valuable learning and the feedback is very positive” - HPRA “ This was one of the most engaging virtual events I have attended so far. Loved the variety of topics” “Keep up the good work” - Sartorius - AstraZeneca For more information please contact Pharmig: T: + 44 (0) 1920 871 999 F: +44 (0) 1920 871 156 E: [email protected] W: www.pharmig.org.uk An Introduction to About Pharmig www.pharmig.org.uk Pharmig is a non-profit making professional organisation, Sterile Manufacturing established in 1991, that represents the interests of individuals who work in, have responsibility for, or work Description alongside microbiology within pharmaceutical, healthcare, cosmetics & NHS Industries. It provides a focus for Designed for those people who are new to industry this continuing professional development and serves as a virtual training course will help you understand what sterile manufacturing is and will cover topics which unique network for the exchange of microbiological include: microbiology, clean room design, sterilisation information through training courses, conferences, processes, sterility assurance, manufacturing methods and publications and its website forum. The Group has grown regulatory oversight. significantly since 1991 expanding the portfolio of products it now offers to the Membership whilst remaining true to Target audience (those new to industry): Microbiologists, the initial needs of microbiologists which include: cleanroom operators, production, quality, engineers, and • Organising meetings, training courses, conferences and sales & marketing producing publications that provide topical information and views on microbiologically related topics It is designed to: • Advancing the science of microbiology and its practical • Get you to think about the risks associated with sterile application manufacturing • Understand the basic elements of sterility assurance • Influencing the development of regulations and guidelines surrounding microbiology The course will support: • Acting as a confidential forum for the dissemination of • Building greater people capability and consistency in your information concerning all aspects of microbiology sterile operations • Reducing quality issues, waste, defects and accidents At the end of this virtual training programme you will: • Being better able to meet your regulators expectations • Have an underpinning awareness of sterile manufacturing • Releasing batches more consistently v get products to the and associated risks. patient more reliably • Attain an introductory understanding and knowledge of • Better management of individual performance key sterile processes and controls Your Presenter: David Keen, Director Pharmaceutical Microbiology & Consulting - Ecolab & Pharmig Chair David is a microbiologist working for investigating significant microbial contamination events Ecolab as Director, Pharmaceutical with suppliers and products. He was lucky enough to be Microbiology in their Lifesciences sent across the world investigating microbiological issues on division. With reference to Pharmig – behalf of the company. If you get caught by him at the bar, David became a Committee member he can bore you to death on the wonders of seaweed. in 2007 and in November 2013 he had the honor of being elected as In 2012 David moved back to GSK at the Ulverston site in the Pharmig Chair. Lake District. This is a large-scale primary API manufacturing site makes bulk sterile antibiotics. It uses isolator technology in a David started life at GSK Barnard Castle. Here he performed primary environment, which was a bit of a steep learning curve. environmental monitoring and clean room qualification David started a new role as a microbiological consultant before moving on to sterile finished product testing. He for Ecolab in March 2018. In this role David utilizes his then moved to a small startup company called SCM Pharma. experience to help Ecolab’s clients with microbiological and Here he set up a new microbiology lab and developed a new manufacturing issues, across the globe. microbiology team. He helped design and qualify the new clean rooms. He then moved from microbiology to project He is experienced in most drug dose forms from sterile management and became the technical manager. needless injection systems, explosive aseptic ampoules to inhalation devices, oral doses of microbial sensitive David then moved to Reckitt Benckiser at their Hull site products and sticky capsules. Plus, a great deal of primary where he discovered the magic and pain of working in an manufacturing to boot. He is now dipping his toe into FMCG environment. His role was to improve microbiological the world of disinfectants and contamination control – a awareness on the site and a large amount of time was spent microbiologist’s best friend. An Introduction to Sterile Manufacturing 21ST AND 22ND APRIL 2021 An Introduction to Sterile Manufacturing (via Zoom) Programme outline running as 2 half-day virtual meetings WEDNESDAY 21st April THURSDAY 22nd April 13.00 – 13.10 13.00 – 13.10 08.00 – 08.10 Welcome: David Keen, Director 08.00 – 08.10 Welcome back Pharmaceutical Microbiology & Consulting - Ecolab & Pharmig Chair 13.10 – 13.55 08.10 – 08.55 Methods of sterilisation 13.10 – 13.55 • Moist and dry heat 08.10 – 08.55 Introduction to sterile manufacturing • Filtration • What does sterile mean? • Irradiation and e-beam • Why do we need sterile products? • Chemical • Sterile vs aseptic – are they the same? 13.55 – 14.00 13.55 – 14.00 08.55 – 09.00 Q&A session 08.55 – 09.00 Q&A session 14.00 – 14.45 14.00 – 14.45 09.00 – 09.45 Process manufacturing 09.00 – 09.45 Introduction to microbiology • Common product dose forms • What is microbiology? • How to manufacture these dose forms • The bacteria, moulds and yeasts, virology, • Isolators RABS and open filling parasites and TSEs • Blow fill seal, freeze drying • Controlling and understanding microbial • Process simulations, media fills and broth growth trials 14.45 – 15.00 14.45 – 15.00 09.45 – 10.00 Q&A session and virtual break 09.45 – 10.00 Q&A session and virtual break 15.00 – 15.45 15.00 – 15.45 10.00 – 10.45 Introduction to cleanrooms 10.00 – 10.45 Sterility assurance • What is a cleanroom • What is sterility assurance? • Cleanroom grades and controls • Risk based manufacturing • Design and equipment • Determination of sterility • Cleanrooms as a contamination control system 15.45 – 15.50 • Cleanroom behaviours 10.45 – 10.50 Q&A session 15.45 – 16.00 15.50 – 16.30 10.45 – 11.00 Q&A session and close of virtual 10.50 – 11.30 Sterile manufacturing and the day one regulations and compliance to GMP • Why is there a need for regulations? • Who regulates the pharmaceutical industry? • Are you inspection ready? KEY RE: TIMES BLUE – BST (British Summer Time) 16.30 – 16.45 GREEN – EST (Eastern Standard Time) 11.30 – 11.45 Q&A session and closing remarks of virtual day two Please note: all information addressed by the speakers are of their own/ their company opinions and viewpoints. 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. An Introduction to Sterile Manufacturing 21ST AND 22ND APRIL 2021 BOOKING FORM: AN INTRODUCTION TO STERILE MANUFACTURING (VIA ZOOM) SPLIT OVER 2 DATES: 21ST & 22ND APRIL 2021 Company: Address: Contact Name (if different from those attending) Email: Tel: DELEGATE ONE DELEGATE TWO Name: Name: Job Title: Job Title: Email: Email: Fee (£/€/$) : Fee (£/€/$) : INFORMATION ON FEES & PAYMENTS • The fees advertised cover 2 half-days on the 21st & 22nd April 2021. • Pharmig cannot reduce this fee if you can only attend one of the morning sessions. • Fees must be paid in advance in order to attend the virtual conference. This can be done via credit card payment OR by an approved company purchase order number FEES - VIRTUAL INTRODUCTION TO STERILE MANUFACTURING (which covers 2 half-day events on the 21st & 22nd April) PHARMIG MEMBER FEES Euro / Dollar NON MEMBER FEES Euro / Dollar Delegate £200 / *€245/ *$284 Delegate £400 / *€470/ *$560 *Fee is higher to cover conversion rates *Fee is higher to cover conversion rates NHS PHARMIG MEMBER FEES NHS NON MEMBER FEES Delegate £100 Delegate £200 For more information contact T: + 44 (0) 1920 871 999 F: +44 (0) 1920 871 156 E: [email protected] W: www.pharmig.org.uk PAYMENT: AN INTRODUCTION TO STERILE MANUFACTURING (VIA ZOOM) SPLIT OVER 2 DATES: 21ST & 22ND APRIL 2021 Please