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SMi’s 4th Annual Conference
Pharmaceutical Microbiology West Coast
June 17th – 18th, 2021 | Virtual Conference: Online Access Only
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The pharmaceutical microbiology industry has seen many changes during the progression into the 21st century. With advances in rapid microbiological methods, revised industry regulation, enhanced knowledge of innovative therapies, novel testing methods, this industry is ever expanding.
Join industry experts to discuss the latest topics and pressing challenges within the industry. Network with industry professionals, discuss revisions in regulatory and guidance documents, explore data integrity considerations and approaches for conventional and rapid microbiology methods, discuss optimised environmental monitoring to best control contamination and gain insight into an industry perspective on alternative endotoxin testing methods and process automation, all contributing to better management of contamination in biopharmaceutical manufacturing.

 

In recent years, Regulatory Agencies have placed an emphasis on the need for all personnel working in aseptic processing environments to have relevant awareness of microbiological concepts and knowledge of proper procedures for prevention and control of microbial contamination.
This workshop will introduce pharmaceutical microbiology and contamination control concepts and practices to those who work in aseptic manufacturing environments, but not experienced in microbiology or new to our industry.
Attendance will benefit managers, supervisors, and operators in manufacturing operations. Personnel from their supporting groups, such as engineering, facility maintenance, and quality assurance will also benefit.
 

Attendees will come away from this workshop with knowledge related to:

  • Types of microbes they may encounter along with environmental and nutritional requirements for the growth of these microbes.
  • The primary sources of microbial contamination and the methods used for detection.
  • The most common microbes detected from air and surface monitoring.
  • How to work biologically safe in our new COVID-19 world.
  • How to control microbial contamination to the proper selection and application of disinfectants.
     
  • Process Development Operators
  • Scale-up Operators
  • Manufacturing Operators
  • Fill/Finish Operators
  • QC Analysts
  • Engineering Personnel
  • Facility Maintenance Personnel
  • QA Personnel
  • Regulatory Affairs Personnel

Workshop programme

All timings are in Pacific Daylight Time (BST-8)

13:30 Opening remarks and introductions

Edward Balkovic

Edward Balkovic, Subject Matter Expert Microbiologist / Virologist and Educator, MicroBio Technical Support
View Bio

13:40 Introduction to the Microbial World

Edward Balkovic

Edward Balkovic, Subject Matter Expert Microbiologist / Virologist and Educator, MicroBio Technical Support
View Bio

• Types of Microbes encountered in Clean Rooms
• Size, Structure, Replication, and Survival mechanisms
• Growth Requirements
• Understanding Fungi
 

14:10 Environmental Monitoring in Aseptic Processing

Edward Balkovic

Edward Balkovic, Subject Matter Expert Microbiologist / Virologist and Educator, MicroBio Technical Support
View Bio

• Potential sources of contamination in controlled environments
• Description of methods for air, personnel and surface monitoring
• Most common microbes recovered from our biopharmaceutical manufacturing environments
 

14:40 Afternoon Break

15:10 Thinking Biologically Safe in our New COVID-19 World

Edward Balkovic

Edward Balkovic, Subject Matter Expert Microbiologist / Virologist and Educator, MicroBio Technical Support
View Bio

• What are Biohazards and How are they Transmitted?
• Where might we find them?
• How can we protect our Personnel and Products?
 

15:40 Disinfectants and Disinfection Practices

Edward Balkovic

Edward Balkovic, Subject Matter Expert Microbiologist / Virologist and Educator, MicroBio Technical Support
View Bio

• Types of Disinfectants
• Selecting the Appropriate Disinfectant
• Proper Application Methods
 

16:10 Closing Remarks

Edward Balkovic

Edward Balkovic, Subject Matter Expert Microbiologist / Virologist and Educator, MicroBio Technical Support
View Bio

16:20 End of workshop

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FEATURED SPEAKERS

Edward Balkovic

Edward Balkovic

Subject Matter Expert Microbiologist / Virologist and Educator, MicroBio Technical Support

Edward Balkovic

Subject Matter Expert Microbiologist / Virologist and Educator, MicroBio Technical Support
Edward Balkovic

Edward S. Balkovic, Ph.D.

Consulting Microbiologist / Virologist
Adjunct Associate Professor - Department of Cell & Molecular Biology, University of Rhode Island

Member - Parenteral Drug Association’s (PDA) Science Advisory Board
 

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Dr. Balkovic is currently a Consulting Microbiologist / Virologist. He also holds an academic appointment as an Adjunct Associate Professor in the Department of Cell & Molecular Biology at the University of Rhode Island. His experience includes 40+ years in the fields of Microbiology & Virology; 30+ years in the Biologics & Biopharmaceutical industries; and 20+ years at Sanofi Genzyme.

At Sanofi Genzyme, he served as a Subject Matter Expert (SME) Microbiologist. He established the microbial identification laboratory serving Genzyme's QC Microbiology testing labs. Dr. Balkovic also conducted investigations, assessments, special projects, training, and developmental technical seminars in the areas of Biotechnology, Pharmaceutical Microbiology, Microbial Awareness, and Contamination Control throughout Sanofi. He has also conducted numerous studies evaluating new and improved methods for microbial detection and identification.

Dr. Balkovic received his doctorate degree in Microbiology and Immunology in the Influenza Research Center at Baylor College of Medicine, Houston, TX. He has held various positions in Contamination Control, Technical Support, Quality Control, Quality Assurance, Regulatory Affairs, Facilities Operations, and Research & Development at both emerging biotechnology and established biopharmaceutical companies. He also has extensive experience and training as a Clinical Virologist & Microbiologist. Previously, he supervised the National Virology Reference Lab serving all of the U.S. Dept. of Veterans Affairs Medical Centers and was also a Senior Research Virologist at a major vaccine manufacturer - Connaught Labs (now Sanofi Pasteur).

He is a member of the Parenteral Drug Association’s (PDA) Science Advisory Board. He also served on the Program Planning Committee for the PDA Global Pharmaceutical Microbiology Conference (2007 – 2017) and the Conference Co-Chair in 2009 and 2010. He is a member of a PDA Task Force preparing a Technical Report on conducting Microbial Investigations. Recipient of 2017 PDA Distinguished Service Award.

At the University of Rhode Island, Dr. Balkovic teaches in the areas of Clinical Microbiology & Virology, Vaccine Development, Emerging Infectious Diseases, Microbial Forensics, Biowarfare & Bioterrorism, Good Manufacturing Practices, and Biotechnology Manufacturing, Product Development & Evaluation.

 

 

Contact information: Phone: 508-450-2502 email: edbalkovic@gmail.com
 

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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