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29-10-2019 (Singapore)

P40096 Practical Facilities Management in Pharmaceutical Industry
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Practical Facilities Management in Pharmaceutical Industry

29 – 30 October 2019 | Mandarin Orchard Hotel, Singapore

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REGISTER 2 DELEGATES & THE 3RD COMES FREE!

overview

Key Learning Outcomes

  • Regulatory and Compliance requirements in pharma facilities management (FM)
  • Critical touch points in Facilities Monitoring and Reporting
  • Best practices in Clean Room End-to-end management
  • Standard operations and maintenance of Non-clinical facilities
  • Practical labs and production asset management
  • Life cycle management in Pharma facilities & equipment
  • Quality Risk Management – essentials for Facilities & Engineering managers
  • Key strategies for outsourcing pharma FM
  • Pharma & Quality 4.0 and implications on facilities management

Case studies and practical workshops

  • Drug Plants – difference between biologics vs chemical
  • Facilities for Continuous Process-based products
  • OEM Agreements for High-grade lab equipment
  • Auditing Contract Manufacturers’ sites

Who Should Attend

This practical seminar is an indispensable guideline in facility operations for pharmaceutical manufacturing, CRO, CMO, warehousing & distributors, and aimed at

  • Facilities engineering & management
  • Process Engineering
  • Continuous improvement
  • Maintenance, QA/QC Engineering
  • Compliance and audit
  • Reliability Engineering
  • Site QA & Compliance Specialists
  • Production, Manufacturing Engineering & Management
  • R&D management
  • Facilities Management Service providers
  • Equipment vendors

What Attendees Like About Our Life Science Programmes

“The course enabled me to improve general understanding on Pharma regulations, as well as participate in active discussion with other trainees.”

Chng Kien Peng, Executive Director, Xepa-Soul Pattinson (S) Pte Ltd

The programme includes good overview information on pharma strategies across the ASEAN region. I enjoyed the global drug trends discussion

Shahanar Sulaiman, Deputy Operations Director, Pharmaniaga Manufacturing Berhad

“Knowledgeable trainer. Course programme covers various aspects to end-to-end process in contract manufacturing; and how to improve quality agreement”

Lee Jong Nyung, TO Manager, Janssen

“Good quality programme with great presentations, specific applications and technology trends in biomanufacturing”

Deng Wei, Senior Manager, Wuxi Biologics

pricing

Packages Price
2 Day TrainingSGD $3495SGD $3295Early BirdEarly Bird

Early Bird Rate: Register and Pay on or before 6 September 2019

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate of 2-day training package only.
For Group Registrations, email register@ibcasia.com.sg or call +65 6508 2401

 

  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.
  • View payment terms and bank transfer details, click here »

Trainer

Bulent Erol
Independent Consultant, Pharma Engineering & Project Management

Bulent has more than 30 years of facilities’ design, automation, engineering and management experience. Over 25 years in pharmaceutical industry, he has led hundreds of minor to major projects for GSK, Amgen, Bilim Pharmaceuticals and many more. He’s specialised in

  • Facility set-up and capital investments: solids, semi-solids, liquids, steriles, freeze-dried products, biosimilars fill & finish, and more
  • EHSS Leadership for Pharma & Process equipment, building, clean rooms, mechanical & electrical services, control systems
  • Validation, qualification, verification, calibration & certification of utilities and equipment
  • Compliance supervision on GMP, GLP, GDP and others
  • Developing and operating computerised management systems
  • Designing, Developing and operating packaging premises
  • Prequalification, qualification of vendors/suppliers, contractors and procurement of systems, facilities and FM services
  • Implementation of continuous improvement activities for sustainable facilities & equipment
  • Planned & unplanned maintenance process
  • Integrated Management System Certification (ISO 9001, ISO 14001, OHSAS 18001)

Agenda

REGULATORY AND COMPLIANCE REQUIREMENTS IN PHARMA FACILITIES MANAGEMENT (FM)

  • GMP, GLP, GDP, CMC Aspects of FM
  • Common Pitfalls in Writing an SOP/Instruction for Each System or Equipment
  • Case Study: Handling A Failure or Malfunction of a GMP/GLP/ GDP/CMC Critical System, Equipment or Instrument
  • Sustainability strategies in pharma facilities management

CRITICAL TOUCHPOINTS IN FACILITIES MONITORING AND REPORTING

  • Main components in facility validations
  • Documentations for qualification (design, installation, operation, performance, process)
  • Inspection and periodic review
  • Monitoring, reporting examples:
    • Equipment: HVAC, water, energy & utilities, refrigerators, freezers, incubators, liquid nitrogen units
    • Environmental conditions: temperature, humidity, differential pressure, atmosphere, air velocity

BEST PRACTICES IN CLEAN ROOM END-TO-END MANAGEMENT

  • Certification & recertification of cleanrooms’ classifications and standards
  • Manage clean rooms’ air pressure, ventilation, humidity, temperature, particle count
  • Minimise contamination risks
  • Future of aseptic techniques
  • Design & construction case studies

FACILITIES FOR CONTINUOUS PROCESS-BASED PRODUCTS

  • Configurations and scales during development and scale-up across manufacturing stages
  • Uncertainty of resource requirement
  • Facility’s level of flexibility
  • Multi-purpose facility
  • From GLP Laboratory to cGMP manufacturing capability for CMP
  • Personnel & procedural controls

STANDARD OPERATIONS AND MAINTENANCE OF NON-CLINICAL ASSETS

  • Total productive maintenance routines
  • Maintenance performance indicators
  • Equipment maintenance: HVAC management
  • Water filtration and purification
  • Electrical systems
  • Environmental control Airborne particulates, microorganisms
  • Airflow, air velocity, humidity, refrigeration, temperature
  • Waste & Energy
  • Maintenance scheduling
  • Exercise: Improving an environmental control programme (ECP)

CASE STUDIES: BIOLOGICS VS CHEMICAL DRUG PLANTS – DIFFERENCES ACROSS FACILITIES AND EQUIPMENT REQUIREMENTS

PRACTICAL LABS AND PRODUCTION ASSET MANAGEMENT

  • Surplus strategies
  • investment recovery programmes
  • Preventive/predictive maintenance and repair
  • Uptime and proactive maintenance

LIFECYCLE MANAGEMENT OF PHARMACEUTICAL FACILITIES AND EQUIPMENT

  • Life cycle assessment analyses of production facilities
  • Strategy & policies
  • Approaches & Processes
  • Procedures and instructions
  • Assessment & validation

DEVELOPING QUALITY RISK MANAGEMENT FRAMEWORK

  • Assessments of risks (safety, purity, strength & identity)
  • ICH Q9 guideline
  • Alarm management systems
  • Disaster planning

Exercise: Assessing Functionality of System or Equipment – Best Practices What does “proper/uninterrupted function” mean?

OEM AGREEMENTS FOR HIGH-GRADE LAB EQUIPMENT

  • Maintenance coverage: warranty, effective & expiration, service levels
    • Key clauses & negotiation: Early cancellation/termination costs and opt-out
    • Auto-renewable
    • Payment terms
  • Vendor and system availability

STRATEGIES FOR OUTSOURCING PHARMA FM

  • Efficiency gains, savings and net present value (NPV) impacts
  • Service level agreements and KPIs
  • Continuing partnership vs competitive tender
  • Cost reduction strategies
  • Renegotiation in outsourcing contracts
  • RFP process consideration for sponsors and bidders
  • Implementation of the signed contract – governance processes

PHARMA 4.0 AND IMPLICATIONS ON FACILITIES MANAGEMENT/MAINTENANCE

  • Innovation to existing technologies
    • Building management systems (BMS) and
    • Manufacturing execution system (MES)
    • Laboratory information management systems (LIMS)
    • Warehouse management systems (WMS)
  • Digitalised building information modelling (BIM)
  • Computerised maintenance management systems (CMMS)
  • Others Mobile water treatment systems for pharma facilities
    • Electronic validation
    • Automated monitoring

when & where

29 - 30 Oct 2019

Mandarin Orchard Singapore, by Meritus
333 Orchard Road, Singapore 238867
Tel: +65 6831 6062 | Fax: +65 6737 3130
Mobile No.: +65 8298 9442
Contact Person: Tan Ai Li
Email: aili.tan@meritushotels.com
Website: www.meritushotels.com

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

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