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CHAIRS FOR 2020:
• James Drinkwater, Chairman, Pharmaceutical and
Healthcare Science Society
• Olivier Chancel, Sterility and Aseptic Practices Expert,
boehringer ingelheim
FEATURED 2020 SPEAKERS iNClUDE:
• luis Meirinhos-Soares, GMP Inspector, infarmed iP
• Tim Eaton, Sterile Manufacturing Specialist,
AstraZeneca
• Pratixa Patel, Senior Director, Microbiology and
Stability Sciences, gSK
• ian Symonds, Pharmaceutical Consultant, SDA Pharma
• Michael Song, Senior Manager, Medimmune
• Maria Jose Zafra-Domene, Microbiology QC Team
Leader, MeiragTx
• ingo Spreitzer, Deputy Head Section Microbial Safety,
Paul Ehrlich institut
• Jim Polarine, Senior Technical Service Manager, STERIS
Corporation
HigHligHTS FOR 2020:
• Discuss the regulatory expectations and supportive
guidance on bio-contamination control and monitoring in
aseptic manufacturing of sterile products from PHSS
• gain valuable insight from key opinion leaders in a panel
discussion on the impact of the Annex 1 revisions on
pharmaceutical microbiology
• Examine the common myths and urban legends in the
pharmaceutical industry related to contamination control
from STERIS
• Explore container closure integrity and controls strategies
ensuring product sterility from AstraZeneca
• Revisit the	role	of	the	Offi	cial	Medicines	Control	
Laboratories as the GMP back up from infarmed iP
CONFERENCE: 20TH-21ST
WORKSHOP DAY: 22ND
JAN
2020
COPTHORNE TARA HOTEl, lONDON, UK
SMi group Proudly Presents The 9th Annual...
Discovering optimised contamination control
and the current regulatory landscape
Pharmaceutical
Microbiology UK
www.pharma-microbiology.com
Register online or fax your registration to +44 (0) 870 9090 712
or call +44 (0) 870 9090 711
SMi Pharma
@SMi Pharma
#SMiPharmaMicroUK
bOOK bY 30TH SEPTEMbER AND SAvE £400
bOOK bY 31ST OCTObER AND SAvE £200
bOOK bY 29TH NOvEMbER AND SAvE £100
PlUS iNTERACTivE POST-CONFERENCE WORKSHOP DAY | WEDNESDAY 22ND JANUARY 2020, COPTHORNE TARA HOTEl, lONDON, UK
A: How to Develop a Risk based Approach to
Cleaning and Disinfection
Jim Polarine, Senior Technical Service Manager,
STERiS Corporation
08.30 – 11.40
b: Designing an Environmental
Monitoring Programme
ian Symonds, Director/Pharmaceutical
Consultant, SDA Pharma
12.40 - 15.40
C: Rapid Micro Methods, Endotoxin Testing and lER
Felix Alejandro Montero Julian, Scientifi	c	Director,	bioMerieux
Stefane Schweicher, Business Development Manager Endotoxin
NEC, bioMerieux
15.40 - 18.40
SPONSORED bY:
Pharmaceutical Microbiology UK
CONFERENCE DAY ONE | Monday 20th January 2020 www.pharma-microbiology.com
Register online at www.pharma-microbiology.com
lETTER FROM THE CHAiRS:
Dear Colleagues,
As chair of SMi’s 2020 Pharmaceutical Microbiology UK Conference
and on behalf of SMi Group, I am delighted to cordially invite you to our
conference and workshop day.
At the very core of pharmaceutical microbiology is the accurate and
reliable detection of microorganisms that would otherwise contaminate
the pharmaceutical products manufactured. This demand for more
rapid	methods	for	detection	and	identifi	cation	will	be	accompanied	by	
equally important areas such as: contamination control strategies and
environmental monitoring, process automation, and discussing updates to
meet regulatory requirements.
This year’s conference will explore guidance and regulation including
the regulatory expectations on bio-contamination control and insights
into the impact of Annex 1 revisions on sterile pharmaceutical product
manufacturing. Furthermore, there will be an exploration into microbial
detection as well as environmental monitoring and contamination controls.
This year’s agenda will also assess novel and emerging therapies of the
biopharmaceutical industry and ATMP community assessing the key
developments	in	the	fi	eld.	The	pharmaceutical	microbiology	workshop	
day will discuss how to develop risk based approaches to cleaning and
disinfection, designing an environmental monitoring programme and
rapid micro methods, endotoxin testing and LER through three insightful
interactive workshops.
We hope you can join us to explore novel and developing technologies
that tackle the most pressing challenges and push innovation in the world
of pharmaceutical microbiology.
Kind regards
Olivier Chancel, James Drinkwater,
Sterility and Aseptic Chairman,
Practices Expert, Pharmaceutical and
boehringer ingelheim Healthcare Science Society
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Olivier Chancel, Sterility and Aseptic Practices Expert, boehringer
ingelheim
gUiDANCE AND REgUlATiON
KEYNOTE PRESENTATiON
9.10 Regulatory expectations and supportive guidance on
bio-contamination control and monitoring in Aseptic
manufacturing of sterile products
•	Regulatory	requirements	e.g.	Annex	1,	2,	Regulatory	expectations	
e.g. Q&A, Blogs, supportive GMP Guidance e.g. PHSS, BioPhorum
(BPOG) – how they relate and current harmonization initiatives
•	Preparation	of	a	Contamination	Control	Strategy	(CCS)	–	an	
Annex 1 requirement and Considerations in preparation of an
Aseptic-Containment Strategy (ACS) if toxic or biologically active
products are aseptically processed and/or cross contamination
control is required
•	Risk	based	rationale	and	supporting	risk	assessments	to	setting	
environmental monitoring locations and sampling frequencies –
PHSS and BPOG collaboration initiative
James Drinkwater, Chairman, Pharmaceutical and Healthcare
Science Society
9.50 Annex 1 Revision
•	History	of	Annex	1
•	Current	Annex	1	key	elements
•	Early	indicators	of	the	changes	expected	in	Annex	1
•	Industry	comments	regarding	the	draft	published	in	2017
•	Where	now	for	Annex	1?
ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma
10.30 The Role of the Official Medicines Control laboratories as the gMP
back-up
•	 What	is	and	What	is	not	an	Offi	cial	Medicines	Control	Laboratory	(OMCL)
•	The	role	of	OMCLs	as	the	analytical	hands-on	support	to	GMP	
Inspections
•	Pre-market	and	Post-market	activities	of	OMCLs
•	Examples	of	Good,	Not-So-Good	and	Bad	Practices	as	seen	from	
the authorities perspective
luis Meirinhos-Soares, GMP Inspector, infarmed iP
11.10 Morning Coffee
PANEl DiSCUSSiON
11.40 The impact of the Annex 1 Revision on Pharmaceutical
Microbiology
•	Which	RMM	technologies	are	being	used	without	regulatory	
confl	ict	on	microbiological	sampling	results	-	Is	industry	ready	for	
integration	of	digital	platforms?
•	The	removal	of	contamination	risk	from	operators	through	use	of	
gloveless	cells	and	robotics	in	fi	lling	platforms
•	What	does	the	unity	of	environmental	classifi	cation,	qualifi	cation	
and process monitoring mean to EM programs and data
management	of	total	particulate	and	microbiological	samples?
•	 How	do	we	manage	risks	associated	with	aseptic	manufacturing	
of toxic and biologically hazardous products such as EM sample
contamination,	product	cross	contamination	and	personnel	exposure?
•	Assessing	the	disinfection	rotation	section	on	the	use	of	multiple	
disinfectants to prevent the development of resistant strains – is
there	enough	evidence?
•	Revisiting	the	potential	latent	risk	of	VBNC	and	stressed	microbial	
contamination in sterile product manufacturing
Moderator: Olivier Chancel, Sterility and Aseptic Practices Expert,
boehringer ingelheim
Panellists:
James Drinkwater, Chairman, Pharmaceutical and Healthcare
Science Society
ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma
luis Meirinhos-Soares, GMP Inspector, infarmed iP
Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca
Jim Polarine, Senior Technical Service Manager, STERiS Corporation
MiCRObiAl DETECTiON AND iDENTiFiCATiON
12.40 New At-line Automated Mycoplasma Testing: A Performance
Evaluation of bioFire Mycoplasma
•	Current	methods	description	
•	New	technology:	how	it	works?	What	are	the	benefi	ts?
•	Internal	validation	data	according	to	Pharmacopeia	guidelines
Sylvanie Cassard guilloux, Global Solution Manager,
bioMerieux
13.20 Networking lunch
14.20 Current status of the MAT and rFc
•	Foreseen	modifi	cation	of	MAT	2.6.30.
•	Feedback	on	draft	rFc	2.6.32.
•	European	and	global	situation	of	MAT	and	rFc
ingo Spreitzer, Deputy Head Section Microbial Safety,
Paul Ehrlich institut
ENviRONMENTAl MONiTORiNg AND CONTAMiNATiON CONTROl
15.00 Automation for incubation and colony counting of Environmental
Monitoring samples: process optimization and data integrity
•	Flexible,	customizable	and	fully-automatic	equipment	for	
incubation and colony counting of environmental monitoring
samples in pharmaceutical production
•	Quality	standardization,	process	digitalization	and	data	integrity	
throughout	the	daily	workfl	ow,	with	full	connectivity	with	the	
existing LIMS platform
•	FLOQSwabs:	a	new	philosophy	for	sample	collection
•	The	critical	issues	in	the	collection	of	the	environmental	sample
•	Improve	effi	ciency	in	evaluation	of	environmental	microbial	
contamination in pharma sector
Sonia Allibardi, Market Access Manager, Copan group
gabriele Savoldi, Business Development Manager,
Copan group
15.40 Afternoon Tea
ASTRAZENECA SPOTligHT PRESENTATiON
16.10 Effective Risk Management of Microbial Contamination
•	Risk	assessment	methods	for	microbial	contamination
•	Quantifi	cation	of	microbial	contamination	using	
environmental monitoring data
•	Meaningful	cleanroom	environmental	monitoring	and	Annex	1	
considerations
•		Effective	risk	based	monitoring	locations	utilising	appropriate	risk	
factors
Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca
16.50 Microbial Control Considerations for Tablet Manufacture
•	Overview	of	microbial	control	strategy	of	the	manufacture	of	oral	
solid dosage forms
•	Summary	of	three	laboratory	based	challenge	studies
- Growth potential of microorganisms in coating suspensions
- Behavior of microorganisms in tablet coating processes
- Survival of microbes in wet granulation processes
•	Application	of	Water	Activity	for	risk-based	testing	plans
Sophie Drinkwater, QC	Technical	Offi	cer,	AstraZeneca
17.30 Chair’s Closing Remarks and Close of Day One
Pharmaceutical Microbiology UK
CONFERENCE DAY TWO | Tuesday 21st January 2020 	 www.pharma-microbiology.com
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
8.30	 Registration & Coffee
9.00	 Chair’s Opening Remarks
	 James Drinkwater, Chairman, Pharmaceutical and Healthcare
Science Society
Environmental Monitoring and Contamination ConTROL
	 KEYNOTE PRESENTATION
9.10	 Container Closure Integrity and Controls Strategies
	 Ensuring Product Sterility
•	Explore and learn when the utilize the different container closure
integrity (deterministic and probabilistic) test methods mentioned
in FDA guidance and USP <1207>
•	New technologies with increased sensitivity…what is a good
detection limit to target and when to draw the line
•	How and when to utilize microbial challenge to help set
manufacturing parameters
•	Holistic approach in defining your container closure integrity
controls strategy and aseptic assurance
	 Michael Song, Senior Manager, AstraZeneca
	 SPOTLIGHT PRESENTATION
9.50	 Common Myths and Urban Legends in the
Pharmaceutical Industry Related to Contamination Control
•	Disinfectant Quantity – The misconception that more disinfecting
agent is always better for sanitization of surfaces
•	Microbiological Resistance – The misconception that micro-
organisms will develop resistance over time to the use of
disinfectants
•	Disinfection Rotation – The misconception that disinfection rotation
is required to prevent microbiological resistance (i.e., Myth #1)
•	Effectiveness of Isopropyl Alcohol­ – The misconception that
70% Isopropyl Alcohol (IPA) is effective for control of fungal and
bacterial spores
	 Jim Polarine, Senior Technical Service Manager, STERIS Corporation
10.30 	 Morning Coffee
11.00	 Online Microbial Monitoring for Process Control of Pharmaceutical
Waters
•	Current state of real time microbial detection technology
•	Case studies for the implementation of online microbial monitoring
at pharmaceutical facilities
•	Guidance for evaluation and establishment of new microbial limits
•	The Pharmacopeia and Regulatory positions on validation of
alternative microbial methods
	 James Cannon, Head of OEM and Markets,
	 Mettler Toledo
11.40	 Commissioning of a brand-new cleanroom facility from the
environmental monitoring perspective
	 •	The challenges of commissioning a brand-new facility
	 •	Risk assessment of the cleanroom and the processes
	 •	Establishing a routine Environmental Monitoring programme
	 Maria Jose Zafra-Domene, Microbiology QC Team Leader, MeiraGTx
Microbial Detection and Identification
12.20	 Bacterial Endotoxins Test – Why are my CVs so high?
•	What is correlation of variation and how to apply it in BET
•	What causes high CVs in BET
•	How to identify the root of high CVs
•	How to mitigate high CVs
Veronika Wills, Manager, Technical Services,
Associates of Cape Cod International
13.00	 Networking Lunch
	 GSK SPOTLIGHT SESSION
14.00	 Aseptic Audit Observations
	 •	What auditor/inspector expectations are
	 •	What audit finding classifications can be used
	 •	Examples of audit observations
	 •	Keeping up to date
	 Di Morris, Audit Manager CAG, GSK	
14.40	 	Microbial Robustness in Product Design
•	Impact of product design on manufacturing
•	Going beyond Pharmacopeia Requirements
•	Assessing the effectiveness of Microbial controls
Pratixa Patel, Senior Director, Microbiological and Stability Sciences,
GSK
15.20	 Afternoon Tea
NOVEL AND EMERGING THERAPIES
15.50	Importance of Microbiological Standards for Personalized Medicines
and Compounding
	 •	 Review of current trends and practices in EU and US
	 •	 Implementation of technological advancements and other best
practices
	 •	 Review of new guidances, guidelines, and regulatory
enforcement activities
	 •	 A look into the future of global personalized medicine
	 Jason McGuire, VP, Quality and Regulatory, Fagron
16.30	 Microbial Risk Assessment for Non-Sterile Oral Dosage Forms
	 •	 Problem statement
	 •	 Risk Assessments
	 •	 Control strategy
	 •	 Objectionable organisms
	 •	 Conclusions
	 David Elder, Principal Consultant, David P Elder Consultancy
17.10	 Chair’s Closing Remarks and Close of Day Two
Engage with top microbiologists in our
microbiology focused conference
Hear from 20+ presentations on the contamination
control and environmental monitoring
Network with industry  pharma leaders
in the exhibition area
Register online at www.pharma-microbiology.com
b: Designing an Environmental Monitoring Programme 12.40 - 15.40
Workshop leader:
ian Symonds, Director/Pharmaceutical Consultant, SDA Pharma
Workshop overview:
Environmental monitoring has a very limited capability of providing assurance of good hygiene control, therefore it must be optimised, based upon a risk
assessment. The workshop will provide information regarding the contamination challenges from the environment, operators, equipment failure and design
limitations. In addition, the workshop will discuss the monitoring techniques and instruments used to generate the data and will involve some practical exercises.
At the end of the workshop, the delegates will have a clear understanding of the limitations and strengths of environmental monitoring and how to design and
execute the monitoring programme.
About the Workshop leader:
Recently established SDA Pharma Limited with co-managing Director Mike Davies. With almost 80 years’ experience in the industry SDA can provide
a	wide	range	of	services	form	facility	design	and	Qualifi	cation	support	to	bespoke	training	and	regulatory	compliance	advice.	Having	previously	
worked at GSK Global Quality, Ian was responsible for setting and monitoring Quality standards for the Global Manufacture and Supply division for
pharmaceutical sterile manufacturing operations worldwide. Following the merger of GlaxoWellcome and SmithKlineBeecham in 2000, he established
a team of subject matter experts to establish a common set of compliance standards for the new GSKs Quality Management System. Ian continued to
lead that team right up to his retirement in 2018. As a leading Company Subject Matter Expert, regarding the manufacture of sterile parenteral products,
Ian leads an expert team in carrying out Due Diligence evaluation, internally and externally focusing on facility, equipment and capability. These activities took
him	to	all	parts	of	the	world	including	Russia,	China,	South	America,	USA	,	India,	Africa	and	many	other	locations.	In	2017,	he	was	awarded	the	honour	of	Senior	
Fellow GSK. External professional involvement includes membership of the Pharmaceutical  Healthcare Sciences Society (PHSS) where he is an active member of
the Biocontamination Control Interest Group.
A: How to Develop a Risk based Approach to Cleaning and Disinfection 8.30 - 12.30
Workshop leader:
Jim Polarine, Senior Technical Service Manager, STERiS Corporation
Workshop overview:
This workshop will cover the current industry trends and best practices in disinfectant global regulations,
rotation, disinfectant application methods, application frequencies, residue removal and rinsing
strategies, disinfectant validation and a case study in bioburden control will be covered. CAPA
investigations related to contamination control in cleanroom operations will be covered. Annex I (Draft
2018),	FDA	Warning	Letters,	FDA	483s,	and	PDA	Technical	Report	No.	70	sections	will	be	covered	which	
relate to the topics mentioned. The workshop will focus on industry trends and industry best practices
based on 20 years of global industry experiences.
About the Workshop leader:
Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been
with STERIS Corporation for eighteen years. His current technical focus is microbial
control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA
Michael S. Korczynski Award recipient. He has lectured in North America, Europe,
Middle East, Asia, and Latin America on issues related to cleaning and disinfection
and microbial control in cleanrooms. Mr. Polarine is a frequent industry speaker
and published several PDA book chapters and articles related to cleaning and disinfection and
contamination control. He is active as co-chair on the PDA’s microbial investigations task force. He
was	a	co-author	on	PDA’s	Technical	Report	#70	on	Cleaning	and	Disinfection.	Mr.	Polarine	teaches	
the cleaning and disinfection course at the PDA Aseptic Processing Course and at the University
of Tennessee’s Parenteral Medications Course. Mr. Polarine is currently President Elect for the PDA
Missouri	Valley	and	Technical	Coordinator	for	the	IEST.		Mr.	Polarine	graduated	from	the	University	of	
Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with
the	Department	of	Veterans	Affairs	in	St.	Louis,	MO	and	as	a	biology	and	microbiology	instructor	
at the University of Illinois. His main hobby is storm chasing and is very active in tornado research
and tornado safety.
Agenda
8.20 Registration  Coffee
8.30 Opening remarks and introductions
9.00 A Risk based Cleaning and Disinfection Program
• Cleaning and Disinfection Methods and
Frequencies
• Disinfectant Rotation
• Rinsing and Residue Removal Frequencies
9.35 bringing the Cleanroom Online After a Worst-
Case Event
• Cleaning Steps Cleanroom Control
• Triple Cleaning Methods and Case Study
• Cleanroom Utilities and Operations Online
10.10 Coffee break
10.30 Disinfectant validation
• Requirements for Manufacturers
• Requirements for Pharmaceutical, biotech,
and Medical Device industries
• Case Studies in Disinfectant validation
11.05 Continuation of Disinfectant validation and
Contamination Control Case Studies
• Overview of Disinfectant validation
• Case Studies in Contamination Control
• Methods to Proactively Prevent bioburden
from Entering Cleanrooms
11.40 Closing remarks
12.00 lunch
C: Rapid Micro Methods, Endotoxin Testing and lER 15.40 - 18.40
Workshop leaders:
Felix Alejandro Montero Julian, Scientifi	c	Director,	bioMerieux
Stefane Schweicher, Business Development Manager Endotoxin NEC, bioMerieux
Workshop overview:
The control of objectionable microorganisms and endotoxins in pharmaceutical products is vital to
ensure the complete safety from diverse immune reactions associated with exposure. As products
become more complex, rapid micro methods and alternative endotoxin testing and LER become
more	routine	and	signifi	cant,	which	suggests	continuous	assessment	and	validation.	This	workshop	
will start with a revision of the current regulatory landscape set by the authorities such as FDA and
EMA. Following this will be an examination of the most robust RMMs, the pros and cons associated,
and prescribed implementation and validation strategies. The 2nd half of the workshop will survey
and	compare	routine	endotoxin	testing	methods	with	proposed	alternatives.	The	workshop	fi	nishes	
off with an expert view of how to address LER and a means of evaluating contamination risk.
About the Workshop leaders:
Felix	is	a	Scientifi	c	Director	of	the	Healthcare	Business	of	bioMerieux.	Felix	has	over	
25 years of experience in industrial and clinical diagnostics and previously served as
the Chemunex RD Director in bioMerieux. Felix graduated from the Autonomous
Metropolitan University in Mexico as Industrial Biochemistry Engineer and obtained a
PhD in Immunology from the Aix Marseille II University in France. Felix is a member of
different	scientifi	c	organizations	(PDA,	ISAC)	and	served	as	an	expert	in	a	panel	for	
the Development of Compendial Rapid Sterility Tests for the USP. Felix has been and continues
to be extensively involved in the implementation and acceptance of rapid and alternative
microbiological methods. He is a prominent speaker at congresses and conferences and a
regular contributor to bioMerieux whitepapers.
Stéphane got a inter university degree in Cytometry and universities of Grenoble  Reims. He worked for 10 years at various spin-off, biotech, CMO many
in	the	fi	eld	of	cancer	immunotherapy.	Before	moving	to	sales	as	account	manager	for	endotoxin	(Lonza)	and	after	in	the	fi	eld	of	lab	automation	(Tecan).	
Stephane joined bioMérieux as Business development manager endotoxin in Jan 2019 for the Northern European Countries.
Agenda
15.40 Registration and Coffee
16.00 Update on RMM Regulation
• Regulatory Framework
16.35 Evaluating and validating the best RMM
Application based on Your Needs
• Technologies
• validation strategy
• implementation
17.10 Afternoon Tea
17.30 Endotoxin Detection
• Regulation: what is new?
• fFc testing
• validation
18.05 lER
• What is lER?
• PDA Technical Report 82
18.40 Closing remarks
iNTERACTivE POST CONFERENCE WORKSHOP DAY
WEDNESDAY 22ND JANUARY 2020 | COPTHORNE TARA HOTEl, lONDON, UK
SPONSORSHiP AND EXHibiTiON OPPORTUNiTiES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities
exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing
number of companies benefiting from sponsoring our conferences please call: Alia Malick, Director on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, inc. (ACC) has been a
leader in endotoxin and (13)-ß-D-glucans	detection	products	and	services	for	nearly	45	years.	ACC	pioneered	LAL	testing	
methodology	and	was	the	fi	rst	FDA	licensed	company	to	manufacture	LAL	reagents.
www.acciusa.com/acc/index.html
bioMérieux, inc. Pioneering Diagnostics bioMérieux provides a wide range of solutions for microbiological control dedicated
to	the	pharmaceutical	industry.	bioMérieux	provides	solutions	for	in-process	controls	and	fi	nal	product	testing.	From	surface	
and	personnel	monitoring	to	air	sampling,	microbial	detection	and	identifi	cation,	bioMérieux	helps	the	pharmaceutical	
industries manage microbiological risks and achieve compliance.
www.biomerieux.com/en/industry-solutions
With a rightful reputation for innovation, COPAN is the world leading manufacturer of collection and transport systems.
In like manner, COPAN’s collaborative approach to pre-analytics has resulted in the development of FLOQSwabs®,
ESwab®, UTM® and modular laboratory automation, WASP® and WASPLab®. For further information on COPAN, visit
www.copangroup.com
METTlER TOlEDO Thornton	has	a	long	history	of	delivering	real	time,	continuous	measurement	products	specifi	cally	designed	
for	 regulated	 pharmaceutical	 water	 systems	 such	 as	 Conductivity,	 TOC,	 and	 Ozone.	 The	 7000RMS	 Real	 time	 Microbial	
System instantly detects and counts microbial (bioburden) presence enabling increased sensitivity, better process control,
improved product quality, and reduced risk. www.mt.com
Microgenetics is a biotech company specialising in microbiology, with two products currently:
•			SmartControl,	 allowing	 easy	 capture	 and	 analysis	 of	 microbiological	 environmental	 monitoring	 data	 and	 is	
pre-validated for GMP compliance
•			SwiftDetect,	an	ultra-sensitive	rapid	sterility	test	capable	of	detecting	a	single	cell	in	a	large	sample	volume	in	6	hours	
microgenetics.co.uk
Reading Scientific Services limited (RSSl) provides analytical, investigational, consultancy and training services to clients
in the global pharmaceutical, biopharmaceutical and healthcare industries. Our GMP compliant facilities are located
in	 the	 UK	 and	 with	 our	 team	 of	 more	 than	 300	 dedicated	 employees,	 we	 ensure	 that	 every	 project	 is	 performed	 with	
our	 commitment	 to	 outstanding	 quality,	 scientifi	c	 excellence	 and	 customer	 satisfaction.	 We	 offer	 a	 large	 portfolio	 of,	
chemical, physical, biochemical and microbiological services providing support through the full drug product life cycle. Our
comprehensive range of services include: Microbial Limits testing (EP, BP, USP, CP and JP); Quantitative Endotoxin Analysis;
Preservative	Effi	cacy	Testing;	Environmental	Monitoring	;Water	Testing;	Extractables	and	leachables	studies;	GMP	Batch	
Release ; Stability Studies; Method development and validation; Physical and Structural Characterisation; Contamination
identifi	cation	and	troubleshooting;	Regulatory	and	compliance	training;	Consultancy.	www.rssl.com
veltek Associates, inc. (vAi) is an EPA/FDA registered manufacturing facility, specialising in contamination control. Our
range of sterile disinfectants, sporicides, wipes and process cleaning detergents, complement our sterile, disposable
cleanroom garments which offer comfortable, breathable garments with outstanding particulate performance. Along with
our	environmental	air	sampling	equipment	to	determine	levels	of	contamination	present	in	the	air,	Veltek	is	committed	to	
providing our customers with the highest quality products. https://sterile.com
PROUDlY SPONSORED bY:
Register online at www.pharma-microbiology.com
MARKETiNg PARTNERSHiP OPPORTUNiTiES
Want to know how you can get involved? interested in promoting your services to this market?
Contact Simi Sapal, Marketing Manager on +44(0)207 827 6162 or email: ssapal@smi-online.co.uk
OFFiCiAl MEDiA PARTNERS SUPPORTiNg MEDiA PARTNERS
JOb TiTlE bREAKDOWN
9%
Head/Chief
24%
Microbiologist
45%
Project Manager
15%
Director
7%
Founder/
President/
CEO
COMPANY bREAKDOWN
82%
Pharma
18%
Industry Solution
Providers
155+Microbilogisiut and Industry
Professionals from US,
Europe and Asia
10+Dedicated hours
of networking
NETWORKiNg ATTENDEE gEOgRAPHY
iNFOgRAPHiCS 2019Pharmaceutical
Microbiology Series
SAvE THE DATE
Pharmaceutical
Manufacturing 
Cleanroom Technology
9th - 10th October 2019
London, UK
Pharmaceutical
Microbiology East Coast
29th	-	30th	April	2020
Boston, USA
Pharmaceutical
Microbiology West Coast
18th - 19th June 2020
San Diego, USA
62% UK
8% USA
1% Canada
6% Switzerland
6% France
4% Germany
2% Denmark
2% Netherland
2% Belgium
7% Rest of Europe
Pharmaceutical Microbiology UK 2020
Conference: 20th – 21st January 2020, Copthorne Tara Hotel, London, UK Workshops: 22nd January 2020, Copthorne Tara Hotel, London, UK
4 WAYS TO REGISTER
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
Online at www.pharma-microbiology.com
POST your booking form to: Events Team, SMi Group Ltd,
Ground Floor, India House, 45 Curlew Street, London SE1 2ND
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk
Unique Reference Number 	
Our Reference		 P-307
Payment must be made to SMi Group Ltd, and received before the event, by one of
the following methods quoting reference P-307 and the delegate’s name. Bookings
made within 7 days of the event require payment on booking, methods of payment:
□ UK BACS	 Sort Code 300009, Account 00936418
□ Wire Transfer	 Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
		Swift (BIC): LOYDGB21013, Account 00936418
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Card Billing Address (If different from above):
Documentation
I cannot attend but would like to Purchase access to the following Document Portal/
Paper Copy documentation.	 Price 		 Total
□	Access to the conference documentation
on the Document Portal 	 £499.00 	 + VAT 	 £598.80
□	The Conference Presentations – paper copy 	 £499.00 	 - 	 £499.00
(or only £300 if ordered with the Document Portal)
PAYMENT
vat
VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged
on Document portal and literature distribution for all UK customers and for those EU
Customers not supplying a registration number for their own country here
CONFERENCE Prices	 GROUP DISCOUNTS AVAILABLE
I would like to attend: (Please tick as appropriate)	 Fee		 TOTAL
□	 Conference  Workshop Day	 £2398.00	 + VAT	 £2877.60
□	 Conference only	 £1499.00 	 + VAT 	 £1798.80
□	 Workshop Focus day	 £899.00	 +VAT	 £1078.80	
	
PROMOTIONAL LITERATURE DISTRIBUTION
□	 Distribution of your company’s promotional
	 literature to all conference attendees 	 £999.00	 + VAT	 £1198.80
	
The conference fee includes refreshments, lunch, conference papers, and access to
the Document Portal. Presentations that are available for download will be subject
to distribution rights by speakers. Please note that some presentations November not
be available for download. Access information for the document portal will be sent
to the e-mail address provided during registration. Details are sent within 24 hours post
conference.
□ Book by 30th September to receive £400 off the conference price
□ Book by by 31st October to receive £200 off the conference price
□ Book by 29th November to receive £100 off the conference price
EARLY BIRD
DISCOUNT
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
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events, please tick □
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I agree to be bound by SMi’s Terms and Conditions of Booking.
ACCOUNTS DEPT
Title:	 Forename:
Surname:
Email:
Address (if different from above):
Town/City:	
Post/Zip Code:	 Country: 	
Direct Tel:		 Direct Fax: 		
Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid
immediately and prior to the start of the event. If payment has not been received then credit card details will
be requested and payment taken before entry to the event. Bookings within 7 days of event require payment
on booking. Access to the Document Portal will not be given until payment has been received.
Substitutions/Name Changes: If you are unable to attend you November nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates Novembernot
‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation:Ifyouwishtocancelyourattendanceataneventandyouareunabletosendasubstitute,then
we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made
in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time
cannot be accepted. We will however provide the conferences documentation via the Document Portal to
anydelegatewhohaspaidbutisunabletoattendforanyreason.DuetotheinteractivenatureoftheBriefings
wearenotnormallyabletoprovidedocumentationinthesecircumstances.Wecannotacceptcancellations
of orders placed for Documentation or the Document Portal as these are reproduced specifically to order.
If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any
further liability.
Alterations: It November become necessary for us to make alterations to the content, speakers, timing,venue
or date of the event compared to the advertised programme.
Privacy policy / Opt Out: For full details on our privacy policy please go to
http://smi-online.co.uk/privacy-legals/privacy-policy. If you no longer wish to receive email
updates you can opt out by going to the following webpage http://www.smi-online.co.uk/opt-out
Terms and Conditions of Booking
Delegate Details
venue Copthorne Tara Hotel, London, UK
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: events@smi-online.co.uk or fax +44 (0) 870 9090 712

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SMi Group's Pharmaceutical Microbiology UK 2020

  • 1. CHAIRS FOR 2020: • James Drinkwater, Chairman, Pharmaceutical and Healthcare Science Society • Olivier Chancel, Sterility and Aseptic Practices Expert, boehringer ingelheim FEATURED 2020 SPEAKERS iNClUDE: • luis Meirinhos-Soares, GMP Inspector, infarmed iP • Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca • Pratixa Patel, Senior Director, Microbiology and Stability Sciences, gSK • ian Symonds, Pharmaceutical Consultant, SDA Pharma • Michael Song, Senior Manager, Medimmune • Maria Jose Zafra-Domene, Microbiology QC Team Leader, MeiragTx • ingo Spreitzer, Deputy Head Section Microbial Safety, Paul Ehrlich institut • Jim Polarine, Senior Technical Service Manager, STERIS Corporation HigHligHTS FOR 2020: • Discuss the regulatory expectations and supportive guidance on bio-contamination control and monitoring in aseptic manufacturing of sterile products from PHSS • gain valuable insight from key opinion leaders in a panel discussion on the impact of the Annex 1 revisions on pharmaceutical microbiology • Examine the common myths and urban legends in the pharmaceutical industry related to contamination control from STERIS • Explore container closure integrity and controls strategies ensuring product sterility from AstraZeneca • Revisit the role of the Offi cial Medicines Control Laboratories as the GMP back up from infarmed iP CONFERENCE: 20TH-21ST WORKSHOP DAY: 22ND JAN 2020 COPTHORNE TARA HOTEl, lONDON, UK SMi group Proudly Presents The 9th Annual... Discovering optimised contamination control and the current regulatory landscape Pharmaceutical Microbiology UK www.pharma-microbiology.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 SMi Pharma @SMi Pharma #SMiPharmaMicroUK bOOK bY 30TH SEPTEMbER AND SAvE £400 bOOK bY 31ST OCTObER AND SAvE £200 bOOK bY 29TH NOvEMbER AND SAvE £100 PlUS iNTERACTivE POST-CONFERENCE WORKSHOP DAY | WEDNESDAY 22ND JANUARY 2020, COPTHORNE TARA HOTEl, lONDON, UK A: How to Develop a Risk based Approach to Cleaning and Disinfection Jim Polarine, Senior Technical Service Manager, STERiS Corporation 08.30 – 11.40 b: Designing an Environmental Monitoring Programme ian Symonds, Director/Pharmaceutical Consultant, SDA Pharma 12.40 - 15.40 C: Rapid Micro Methods, Endotoxin Testing and lER Felix Alejandro Montero Julian, Scientifi c Director, bioMerieux Stefane Schweicher, Business Development Manager Endotoxin NEC, bioMerieux 15.40 - 18.40 SPONSORED bY:
  • 2. Pharmaceutical Microbiology UK CONFERENCE DAY ONE | Monday 20th January 2020 www.pharma-microbiology.com Register online at www.pharma-microbiology.com lETTER FROM THE CHAiRS: Dear Colleagues, As chair of SMi’s 2020 Pharmaceutical Microbiology UK Conference and on behalf of SMi Group, I am delighted to cordially invite you to our conference and workshop day. At the very core of pharmaceutical microbiology is the accurate and reliable detection of microorganisms that would otherwise contaminate the pharmaceutical products manufactured. This demand for more rapid methods for detection and identifi cation will be accompanied by equally important areas such as: contamination control strategies and environmental monitoring, process automation, and discussing updates to meet regulatory requirements. This year’s conference will explore guidance and regulation including the regulatory expectations on bio-contamination control and insights into the impact of Annex 1 revisions on sterile pharmaceutical product manufacturing. Furthermore, there will be an exploration into microbial detection as well as environmental monitoring and contamination controls. This year’s agenda will also assess novel and emerging therapies of the biopharmaceutical industry and ATMP community assessing the key developments in the fi eld. The pharmaceutical microbiology workshop day will discuss how to develop risk based approaches to cleaning and disinfection, designing an environmental monitoring programme and rapid micro methods, endotoxin testing and LER through three insightful interactive workshops. We hope you can join us to explore novel and developing technologies that tackle the most pressing challenges and push innovation in the world of pharmaceutical microbiology. Kind regards Olivier Chancel, James Drinkwater, Sterility and Aseptic Chairman, Practices Expert, Pharmaceutical and boehringer ingelheim Healthcare Science Society 8.30 Registration & Coffee 9.00 Chair’s Opening Remarks Olivier Chancel, Sterility and Aseptic Practices Expert, boehringer ingelheim gUiDANCE AND REgUlATiON KEYNOTE PRESENTATiON 9.10 Regulatory expectations and supportive guidance on bio-contamination control and monitoring in Aseptic manufacturing of sterile products • Regulatory requirements e.g. Annex 1, 2, Regulatory expectations e.g. Q&A, Blogs, supportive GMP Guidance e.g. PHSS, BioPhorum (BPOG) – how they relate and current harmonization initiatives • Preparation of a Contamination Control Strategy (CCS) – an Annex 1 requirement and Considerations in preparation of an Aseptic-Containment Strategy (ACS) if toxic or biologically active products are aseptically processed and/or cross contamination control is required • Risk based rationale and supporting risk assessments to setting environmental monitoring locations and sampling frequencies – PHSS and BPOG collaboration initiative James Drinkwater, Chairman, Pharmaceutical and Healthcare Science Society 9.50 Annex 1 Revision • History of Annex 1 • Current Annex 1 key elements • Early indicators of the changes expected in Annex 1 • Industry comments regarding the draft published in 2017 • Where now for Annex 1? ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma 10.30 The Role of the Official Medicines Control laboratories as the gMP back-up • What is and What is not an Offi cial Medicines Control Laboratory (OMCL) • The role of OMCLs as the analytical hands-on support to GMP Inspections • Pre-market and Post-market activities of OMCLs • Examples of Good, Not-So-Good and Bad Practices as seen from the authorities perspective luis Meirinhos-Soares, GMP Inspector, infarmed iP 11.10 Morning Coffee PANEl DiSCUSSiON 11.40 The impact of the Annex 1 Revision on Pharmaceutical Microbiology • Which RMM technologies are being used without regulatory confl ict on microbiological sampling results - Is industry ready for integration of digital platforms? • The removal of contamination risk from operators through use of gloveless cells and robotics in fi lling platforms • What does the unity of environmental classifi cation, qualifi cation and process monitoring mean to EM programs and data management of total particulate and microbiological samples? • How do we manage risks associated with aseptic manufacturing of toxic and biologically hazardous products such as EM sample contamination, product cross contamination and personnel exposure? • Assessing the disinfection rotation section on the use of multiple disinfectants to prevent the development of resistant strains – is there enough evidence? • Revisiting the potential latent risk of VBNC and stressed microbial contamination in sterile product manufacturing Moderator: Olivier Chancel, Sterility and Aseptic Practices Expert, boehringer ingelheim Panellists: James Drinkwater, Chairman, Pharmaceutical and Healthcare Science Society ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma luis Meirinhos-Soares, GMP Inspector, infarmed iP Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca Jim Polarine, Senior Technical Service Manager, STERiS Corporation MiCRObiAl DETECTiON AND iDENTiFiCATiON 12.40 New At-line Automated Mycoplasma Testing: A Performance Evaluation of bioFire Mycoplasma • Current methods description • New technology: how it works? What are the benefi ts? • Internal validation data according to Pharmacopeia guidelines Sylvanie Cassard guilloux, Global Solution Manager, bioMerieux 13.20 Networking lunch 14.20 Current status of the MAT and rFc • Foreseen modifi cation of MAT 2.6.30. • Feedback on draft rFc 2.6.32. • European and global situation of MAT and rFc ingo Spreitzer, Deputy Head Section Microbial Safety, Paul Ehrlich institut ENviRONMENTAl MONiTORiNg AND CONTAMiNATiON CONTROl 15.00 Automation for incubation and colony counting of Environmental Monitoring samples: process optimization and data integrity • Flexible, customizable and fully-automatic equipment for incubation and colony counting of environmental monitoring samples in pharmaceutical production • Quality standardization, process digitalization and data integrity throughout the daily workfl ow, with full connectivity with the existing LIMS platform • FLOQSwabs: a new philosophy for sample collection • The critical issues in the collection of the environmental sample • Improve effi ciency in evaluation of environmental microbial contamination in pharma sector Sonia Allibardi, Market Access Manager, Copan group gabriele Savoldi, Business Development Manager, Copan group 15.40 Afternoon Tea ASTRAZENECA SPOTligHT PRESENTATiON 16.10 Effective Risk Management of Microbial Contamination • Risk assessment methods for microbial contamination • Quantifi cation of microbial contamination using environmental monitoring data • Meaningful cleanroom environmental monitoring and Annex 1 considerations • Effective risk based monitoring locations utilising appropriate risk factors Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca 16.50 Microbial Control Considerations for Tablet Manufacture • Overview of microbial control strategy of the manufacture of oral solid dosage forms • Summary of three laboratory based challenge studies - Growth potential of microorganisms in coating suspensions - Behavior of microorganisms in tablet coating processes - Survival of microbes in wet granulation processes • Application of Water Activity for risk-based testing plans Sophie Drinkwater, QC Technical Offi cer, AstraZeneca 17.30 Chair’s Closing Remarks and Close of Day One
  • 3. Pharmaceutical Microbiology UK CONFERENCE DAY TWO | Tuesday 21st January 2020 www.pharma-microbiology.com Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 8.30 Registration & Coffee 9.00 Chair’s Opening Remarks James Drinkwater, Chairman, Pharmaceutical and Healthcare Science Society Environmental Monitoring and Contamination ConTROL KEYNOTE PRESENTATION 9.10 Container Closure Integrity and Controls Strategies Ensuring Product Sterility • Explore and learn when the utilize the different container closure integrity (deterministic and probabilistic) test methods mentioned in FDA guidance and USP <1207> • New technologies with increased sensitivity…what is a good detection limit to target and when to draw the line • How and when to utilize microbial challenge to help set manufacturing parameters • Holistic approach in defining your container closure integrity controls strategy and aseptic assurance Michael Song, Senior Manager, AstraZeneca SPOTLIGHT PRESENTATION 9.50 Common Myths and Urban Legends in the Pharmaceutical Industry Related to Contamination Control • Disinfectant Quantity – The misconception that more disinfecting agent is always better for sanitization of surfaces • Microbiological Resistance – The misconception that micro- organisms will develop resistance over time to the use of disinfectants • Disinfection Rotation – The misconception that disinfection rotation is required to prevent microbiological resistance (i.e., Myth #1) • Effectiveness of Isopropyl Alcohol­ – The misconception that 70% Isopropyl Alcohol (IPA) is effective for control of fungal and bacterial spores Jim Polarine, Senior Technical Service Manager, STERIS Corporation 10.30 Morning Coffee 11.00 Online Microbial Monitoring for Process Control of Pharmaceutical Waters • Current state of real time microbial detection technology • Case studies for the implementation of online microbial monitoring at pharmaceutical facilities • Guidance for evaluation and establishment of new microbial limits • The Pharmacopeia and Regulatory positions on validation of alternative microbial methods James Cannon, Head of OEM and Markets, Mettler Toledo 11.40 Commissioning of a brand-new cleanroom facility from the environmental monitoring perspective • The challenges of commissioning a brand-new facility • Risk assessment of the cleanroom and the processes • Establishing a routine Environmental Monitoring programme Maria Jose Zafra-Domene, Microbiology QC Team Leader, MeiraGTx Microbial Detection and Identification 12.20 Bacterial Endotoxins Test – Why are my CVs so high? • What is correlation of variation and how to apply it in BET • What causes high CVs in BET • How to identify the root of high CVs • How to mitigate high CVs Veronika Wills, Manager, Technical Services, Associates of Cape Cod International 13.00 Networking Lunch GSK SPOTLIGHT SESSION 14.00 Aseptic Audit Observations • What auditor/inspector expectations are • What audit finding classifications can be used • Examples of audit observations • Keeping up to date Di Morris, Audit Manager CAG, GSK 14.40 Microbial Robustness in Product Design • Impact of product design on manufacturing • Going beyond Pharmacopeia Requirements • Assessing the effectiveness of Microbial controls Pratixa Patel, Senior Director, Microbiological and Stability Sciences, GSK 15.20 Afternoon Tea NOVEL AND EMERGING THERAPIES 15.50 Importance of Microbiological Standards for Personalized Medicines and Compounding • Review of current trends and practices in EU and US • Implementation of technological advancements and other best practices • Review of new guidances, guidelines, and regulatory enforcement activities • A look into the future of global personalized medicine Jason McGuire, VP, Quality and Regulatory, Fagron 16.30 Microbial Risk Assessment for Non-Sterile Oral Dosage Forms • Problem statement • Risk Assessments • Control strategy • Objectionable organisms • Conclusions David Elder, Principal Consultant, David P Elder Consultancy 17.10 Chair’s Closing Remarks and Close of Day Two Engage with top microbiologists in our microbiology focused conference Hear from 20+ presentations on the contamination control and environmental monitoring Network with industry pharma leaders in the exhibition area
  • 4. Register online at www.pharma-microbiology.com b: Designing an Environmental Monitoring Programme 12.40 - 15.40 Workshop leader: ian Symonds, Director/Pharmaceutical Consultant, SDA Pharma Workshop overview: Environmental monitoring has a very limited capability of providing assurance of good hygiene control, therefore it must be optimised, based upon a risk assessment. The workshop will provide information regarding the contamination challenges from the environment, operators, equipment failure and design limitations. In addition, the workshop will discuss the monitoring techniques and instruments used to generate the data and will involve some practical exercises. At the end of the workshop, the delegates will have a clear understanding of the limitations and strengths of environmental monitoring and how to design and execute the monitoring programme. About the Workshop leader: Recently established SDA Pharma Limited with co-managing Director Mike Davies. With almost 80 years’ experience in the industry SDA can provide a wide range of services form facility design and Qualifi cation support to bespoke training and regulatory compliance advice. Having previously worked at GSK Global Quality, Ian was responsible for setting and monitoring Quality standards for the Global Manufacture and Supply division for pharmaceutical sterile manufacturing operations worldwide. Following the merger of GlaxoWellcome and SmithKlineBeecham in 2000, he established a team of subject matter experts to establish a common set of compliance standards for the new GSKs Quality Management System. Ian continued to lead that team right up to his retirement in 2018. As a leading Company Subject Matter Expert, regarding the manufacture of sterile parenteral products, Ian leads an expert team in carrying out Due Diligence evaluation, internally and externally focusing on facility, equipment and capability. These activities took him to all parts of the world including Russia, China, South America, USA , India, Africa and many other locations. In 2017, he was awarded the honour of Senior Fellow GSK. External professional involvement includes membership of the Pharmaceutical Healthcare Sciences Society (PHSS) where he is an active member of the Biocontamination Control Interest Group. A: How to Develop a Risk based Approach to Cleaning and Disinfection 8.30 - 12.30 Workshop leader: Jim Polarine, Senior Technical Service Manager, STERiS Corporation Workshop overview: This workshop will cover the current industry trends and best practices in disinfectant global regulations, rotation, disinfectant application methods, application frequencies, residue removal and rinsing strategies, disinfectant validation and a case study in bioburden control will be covered. CAPA investigations related to contamination control in cleanroom operations will be covered. Annex I (Draft 2018), FDA Warning Letters, FDA 483s, and PDA Technical Report No. 70 sections will be covered which relate to the topics mentioned. The workshop will focus on industry trends and industry best practices based on 20 years of global industry experiences. About the Workshop leader: Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for eighteen years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection and microbial control in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches the cleaning and disinfection course at the PDA Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is currently President Elect for the PDA Missouri Valley and Technical Coordinator for the IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety. Agenda 8.20 Registration Coffee 8.30 Opening remarks and introductions 9.00 A Risk based Cleaning and Disinfection Program • Cleaning and Disinfection Methods and Frequencies • Disinfectant Rotation • Rinsing and Residue Removal Frequencies 9.35 bringing the Cleanroom Online After a Worst- Case Event • Cleaning Steps Cleanroom Control • Triple Cleaning Methods and Case Study • Cleanroom Utilities and Operations Online 10.10 Coffee break 10.30 Disinfectant validation • Requirements for Manufacturers • Requirements for Pharmaceutical, biotech, and Medical Device industries • Case Studies in Disinfectant validation 11.05 Continuation of Disinfectant validation and Contamination Control Case Studies • Overview of Disinfectant validation • Case Studies in Contamination Control • Methods to Proactively Prevent bioburden from Entering Cleanrooms 11.40 Closing remarks 12.00 lunch C: Rapid Micro Methods, Endotoxin Testing and lER 15.40 - 18.40 Workshop leaders: Felix Alejandro Montero Julian, Scientifi c Director, bioMerieux Stefane Schweicher, Business Development Manager Endotoxin NEC, bioMerieux Workshop overview: The control of objectionable microorganisms and endotoxins in pharmaceutical products is vital to ensure the complete safety from diverse immune reactions associated with exposure. As products become more complex, rapid micro methods and alternative endotoxin testing and LER become more routine and signifi cant, which suggests continuous assessment and validation. This workshop will start with a revision of the current regulatory landscape set by the authorities such as FDA and EMA. Following this will be an examination of the most robust RMMs, the pros and cons associated, and prescribed implementation and validation strategies. The 2nd half of the workshop will survey and compare routine endotoxin testing methods with proposed alternatives. The workshop fi nishes off with an expert view of how to address LER and a means of evaluating contamination risk. About the Workshop leaders: Felix is a Scientifi c Director of the Healthcare Business of bioMerieux. Felix has over 25 years of experience in industrial and clinical diagnostics and previously served as the Chemunex RD Director in bioMerieux. Felix graduated from the Autonomous Metropolitan University in Mexico as Industrial Biochemistry Engineer and obtained a PhD in Immunology from the Aix Marseille II University in France. Felix is a member of different scientifi c organizations (PDA, ISAC) and served as an expert in a panel for the Development of Compendial Rapid Sterility Tests for the USP. Felix has been and continues to be extensively involved in the implementation and acceptance of rapid and alternative microbiological methods. He is a prominent speaker at congresses and conferences and a regular contributor to bioMerieux whitepapers. Stéphane got a inter university degree in Cytometry and universities of Grenoble Reims. He worked for 10 years at various spin-off, biotech, CMO many in the fi eld of cancer immunotherapy. Before moving to sales as account manager for endotoxin (Lonza) and after in the fi eld of lab automation (Tecan). Stephane joined bioMérieux as Business development manager endotoxin in Jan 2019 for the Northern European Countries. Agenda 15.40 Registration and Coffee 16.00 Update on RMM Regulation • Regulatory Framework 16.35 Evaluating and validating the best RMM Application based on Your Needs • Technologies • validation strategy • implementation 17.10 Afternoon Tea 17.30 Endotoxin Detection • Regulation: what is new? • fFc testing • validation 18.05 lER • What is lER? • PDA Technical Report 82 18.40 Closing remarks iNTERACTivE POST CONFERENCE WORKSHOP DAY WEDNESDAY 22ND JANUARY 2020 | COPTHORNE TARA HOTEl, lONDON, UK
  • 5. SPONSORSHiP AND EXHibiTiON OPPORTUNiTiES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick, Director on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, inc. (ACC) has been a leader in endotoxin and (13)-ß-D-glucans detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the fi rst FDA licensed company to manufacture LAL reagents. www.acciusa.com/acc/index.html bioMérieux, inc. Pioneering Diagnostics bioMérieux provides a wide range of solutions for microbiological control dedicated to the pharmaceutical industry. bioMérieux provides solutions for in-process controls and fi nal product testing. From surface and personnel monitoring to air sampling, microbial detection and identifi cation, bioMérieux helps the pharmaceutical industries manage microbiological risks and achieve compliance. www.biomerieux.com/en/industry-solutions With a rightful reputation for innovation, COPAN is the world leading manufacturer of collection and transport systems. In like manner, COPAN’s collaborative approach to pre-analytics has resulted in the development of FLOQSwabs®, ESwab®, UTM® and modular laboratory automation, WASP® and WASPLab®. For further information on COPAN, visit www.copangroup.com METTlER TOlEDO Thornton has a long history of delivering real time, continuous measurement products specifi cally designed for regulated pharmaceutical water systems such as Conductivity, TOC, and Ozone. The 7000RMS Real time Microbial System instantly detects and counts microbial (bioburden) presence enabling increased sensitivity, better process control, improved product quality, and reduced risk. www.mt.com Microgenetics is a biotech company specialising in microbiology, with two products currently: • SmartControl, allowing easy capture and analysis of microbiological environmental monitoring data and is pre-validated for GMP compliance • SwiftDetect, an ultra-sensitive rapid sterility test capable of detecting a single cell in a large sample volume in 6 hours microgenetics.co.uk Reading Scientific Services limited (RSSl) provides analytical, investigational, consultancy and training services to clients in the global pharmaceutical, biopharmaceutical and healthcare industries. Our GMP compliant facilities are located in the UK and with our team of more than 300 dedicated employees, we ensure that every project is performed with our commitment to outstanding quality, scientifi c excellence and customer satisfaction. We offer a large portfolio of, chemical, physical, biochemical and microbiological services providing support through the full drug product life cycle. Our comprehensive range of services include: Microbial Limits testing (EP, BP, USP, CP and JP); Quantitative Endotoxin Analysis; Preservative Effi cacy Testing; Environmental Monitoring ;Water Testing; Extractables and leachables studies; GMP Batch Release ; Stability Studies; Method development and validation; Physical and Structural Characterisation; Contamination identifi cation and troubleshooting; Regulatory and compliance training; Consultancy. www.rssl.com veltek Associates, inc. (vAi) is an EPA/FDA registered manufacturing facility, specialising in contamination control. Our range of sterile disinfectants, sporicides, wipes and process cleaning detergents, complement our sterile, disposable cleanroom garments which offer comfortable, breathable garments with outstanding particulate performance. Along with our environmental air sampling equipment to determine levels of contamination present in the air, Veltek is committed to providing our customers with the highest quality products. https://sterile.com PROUDlY SPONSORED bY: Register online at www.pharma-microbiology.com MARKETiNg PARTNERSHiP OPPORTUNiTiES Want to know how you can get involved? interested in promoting your services to this market? Contact Simi Sapal, Marketing Manager on +44(0)207 827 6162 or email: ssapal@smi-online.co.uk OFFiCiAl MEDiA PARTNERS SUPPORTiNg MEDiA PARTNERS JOb TiTlE bREAKDOWN 9% Head/Chief 24% Microbiologist 45% Project Manager 15% Director 7% Founder/ President/ CEO COMPANY bREAKDOWN 82% Pharma 18% Industry Solution Providers 155+Microbilogisiut and Industry Professionals from US, Europe and Asia 10+Dedicated hours of networking NETWORKiNg ATTENDEE gEOgRAPHY iNFOgRAPHiCS 2019Pharmaceutical Microbiology Series SAvE THE DATE Pharmaceutical Manufacturing Cleanroom Technology 9th - 10th October 2019 London, UK Pharmaceutical Microbiology East Coast 29th - 30th April 2020 Boston, USA Pharmaceutical Microbiology West Coast 18th - 19th June 2020 San Diego, USA 62% UK 8% USA 1% Canada 6% Switzerland 6% France 4% Germany 2% Denmark 2% Netherland 2% Belgium 7% Rest of Europe
  • 6. Pharmaceutical Microbiology UK 2020 Conference: 20th – 21st January 2020, Copthorne Tara Hotel, London, UK Workshops: 22nd January 2020, Copthorne Tara Hotel, London, UK 4 WAYS TO REGISTER FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 Online at www.pharma-microbiology.com POST your booking form to: Events Team, SMi Group Ltd, Ground Floor, India House, 45 Curlew Street, London SE1 2ND If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk Unique Reference Number Our Reference P-307 Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-307 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment: □ UK BACS Sort Code 300009, Account 00936418 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18 □ Cheque We can only accept Sterling cheques drawn on a UK bank. □ Credit Card □ Visa □ MasterCard □ American Express SMi Group will apply surcharges to commercial cards Please tick here □ if the card provided is not a commercial card Card No: □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Cardholder’s Name: Signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. Card Billing Address (If different from above): Documentation I cannot attend but would like to Purchase access to the following Document Portal/ Paper Copy documentation. Price Total □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80 □ The Conference Presentations – paper copy £499.00 - £499.00 (or only £300 if ordered with the Document Portal) PAYMENT vat VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on Document portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here CONFERENCE Prices GROUP DISCOUNTS AVAILABLE I would like to attend: (Please tick as appropriate) Fee TOTAL □ Conference Workshop Day £2398.00 + VAT £2877.60 □ Conference only £1499.00 + VAT £1798.80 □ Workshop Focus day £899.00 +VAT £1078.80 PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80 The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. Presentations that are available for download will be subject to distribution rights by speakers. Please note that some presentations November not be available for download. Access information for the document portal will be sent to the e-mail address provided during registration. Details are sent within 24 hours post conference. □ Book by 30th September to receive £400 off the conference price □ Book by by 31st October to receive £200 off the conference price □ Book by 29th November to receive £100 off the conference price EARLY BIRD DISCOUNT Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: If you would like to continue to receive email updates about our events, please tick □ Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. ACCOUNTS DEPT Title: Forename: Surname: Email: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received. Substitutions/Name Changes: If you are unable to attend you November nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates Novembernot ‘share’ a place at an event. Please make separate bookings for each delegate. Cancellation:Ifyouwishtocancelyourattendanceataneventandyouareunabletosendasubstitute,then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to anydelegatewhohaspaidbutisunabletoattendforanyreason.DuetotheinteractivenatureoftheBriefings wearenotnormallyabletoprovidedocumentationinthesecircumstances.Wecannotacceptcancellations of orders placed for Documentation or the Document Portal as these are reproduced specifically to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It November become necessary for us to make alterations to the content, speakers, timing,venue or date of the event compared to the advertised programme. Privacy policy / Opt Out: For full details on our privacy policy please go to http://smi-online.co.uk/privacy-legals/privacy-policy. If you no longer wish to receive email updates you can opt out by going to the following webpage http://www.smi-online.co.uk/opt-out Terms and Conditions of Booking Delegate Details venue Copthorne Tara Hotel, London, UK □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: events@smi-online.co.uk or fax +44 (0) 870 9090 712