Contact us

A-Z of Sterile Products Manufacture Training

Dates

Times

5 days

Location

In-Person - Manchester, United Kingdom

Availability

About This Course

From Aseptic practices to Z values and everything in between!

For over 30 years we have hosted this highly participative and popular sterile products manufacturing training course. Thousands of pharmaceutical industry professionals around the world have benefitted from learning about key scientific, technical and regulatory challenges associated with Good Manufacturing Practice (GMP) of sterile products manufacturing. Whether you need to meet EU, FDA or any other regulatory agency’s needs, this course gives you the knowledge, skills and tools to succeed.

A pharma product administered parenterally bypasses the body’s natural defense mechanisms. Consequently, any quality defect could potentially cause serious harm to the end user. Linking everything you do to providing a safe and effective formulation to the end user is critical. Our manufacturing sterile products training course concentrates on how product quality is assured via practical and interactive review of the science and compliance behind sterile products manufacturing.

This course is offered either virtually, or in-person at a hotel venue. If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.

This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development.

This course has been revised in line with the revisions to EudraLex Volume 4, Annex 1.

Key Learning Objectives

Completion of this sterile products training course will enable you to:

  • Describe a typical sterile production process and the facility, equipment and utilities associated with sterile product manufacture
  • Know what aspects require detailed definition, validation and ongoing monitoring
  • Know the typical failure modes and how to determine most probable root cause and mitigation strategies
  • Understand how the key attributes of a sterile product impact:
    • The pharmaceutical quality system
    • The organization
    • The management oversight process
    • Risk management and mitigation
    • The end user or patient

We want you to learn, be engaged and have fun as well as take away practical knowledge that is immediately useful back in the workplace. Carefully designed case studies, teamwork tasks and problem-solving exercises (facilitated by highly experienced course tutors) ensure that you learn by doing.

Course Outline

  • Regulatory Standards for Sterile Products
  • Creating the Controlled Environment

    The design, validation, operation and maintenance of:

    • Cleanrooms
    • Isolators and restricted access barrier systems (RABS)
    • Sterile preparation
    • Steam
    • Water (from bore hole to water for injection)
  • Aseptic and Terminal Sterilization (TS) Production Methods
  • Environmental Monitoring (The What, Why and How)
  • Routine Disinfection (A Quality Critical Activity)
  • Critical Utilities
  • Sterilization Processes: Everything You Need to Know
    • Moist heat (autoclaves)
    • Dry heat (ovens and tunnels)
    • Filtration
    • Irradiation
    • Vaporized hydrogen peroxide (VHP) surface sanitization
  • Process Simulations (Media Fills): The What, Why, How and What If
    • Regulatory requirements
    • How to design media fills “fit for purpose”
    • Best industry practice
    • What to do when they fail
  • Container Integrity and Particulate Inspection
    • How to validate and test
    • How to manage failures (from root cause investigation to corrective and preventive action (CAPA) implementation)
  • People Issues
    • Gowning and good aseptic practices
    • How to motivate, lead by example and understand, promote and enforce good aseptic behaviors
  • Problem Solving and Troubleshooting (Dealing With the Unplanned)
    • What to do when things go wrong

Course Tutors

Course tutors will be selected from the following:

Darren Jones – With extensive operational QA experience including being an MHRA inspector specializing in sterile products, Darren is an internationally recognized expert in his field. His unique insight is indelibly linked to how to audit in a way that provides accurate identification of GMP deficiencies and proportionate assessment of product, patient and GMP risk.

Sheila Shadbolt – Sheila is an experienced quality professional with over 15 years’ experience in pharmaceutical manufacturing environments in both human and veterinary products within small molecule API, sterile products, vaccines and biological product manufacture. She has extensive knowledge of worldwide regulatory agency expectations for medicinal product development, manufacture, and distribution.

James Culyer – James has over 20 years’ experience in technical, quality and managerial roles within parenteral, non-sterile liquid, oral solid dosage and inhalation product manufacture. He has extensive experience managing all aspects of manufacturing site quality management systems and is a specialist in global supply chain assurance activities.

Philip Rose – Philip Rose has over 20 years of experience in a wide range of roles within the pharmaceutical industry, from QC through to senior management and as a Qualified Person. Most recently, he worked as a Lead Senior GMDP Inspector for the UK competent authority, the MHRA. Within this role, he inspected some of the most complex cases globally against EU GMP and GDP in areas such as biologicals (including vaccines), steriles, non-steriles, ATMPs and specials.

Ian Harwood – Ian is a GMP Consultant with over 20 years’ industry experience, including extensive knowledge of Pharmaceutical Quality Systems and GMP for steriles, biotech, IMPs, radiopharmaceuticals and unlicenced medicines. He spent 8 years as a GMP Inspector with the MHRA and is eligible to act as a Qualified Person.

Discounts

Multi-delegate discounts available. Discounts also offered to NHS staff and charities.

  • Really educational course. Good dynamic between lecture and teamwork. Not just a read through of guidelines but a proper insight to what GMP is. The course has changed my mindset on manufacturing of sterile products.
    Maria Thestrup Kristensen
    Novo Nordisk, Denmark
  • The numerous practical examples from the previous experience of the tutors when they were inspectors were priceless. Another great NSF training course! I have done a number of NSF courses and have found them all to be excellent.
    Paul O'Shea
    Servier Laboratories PTY, Australia
  • The trainers are real professionals. You get a really good and valuable overview of sterile manufacturing. A course which is definitely worth it!
    Saskia Spahn
    Hoffman-La Roche, Switzerland

Additional Recommended Courses

CQI & IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements

This virtual instructor-led CQI/IRCA accredited course provides learners with the skills and knowledge that have taken many ​experienced ​auditors ​decades ​to ​develop. This course is fundamental to achieving CQI/IRCA Lead Auditor status. ​During ​the ​course, ​learners ​will ​plan, perform, ​and ​report ​audits ​based ​on ​case ​studies ​that ​simulate ​internal, ​supplier, ​and ​third-party ​audits ​utilizing ​MDSAP ​audit criteria. ​Learners ​will ​participate ​in ​simulated ​auditing ​exercises ​that ​include ​planning and performing audit activities, ​evaluating ​audit ​evidence, and documenting audit findings.

The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for non-native English-speaking learners, and learners with disabilities).

Learners should enter the QMS Lead Auditor course with a basic understanding of ISO 13485:2016. Mandatory prerequisite reading and a prerequisite competency assessment will be provided upon enrollment. These prerequisites must be completed in advance of the course start date.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.

By the end of this course you should be able to:

· Describe the purpose of:

  • Quality management systems
  • Quality management system standards
  • Management system audits
  • Third-party certification

· Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011:2018

· Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485:2016 and MDSAP participating country-specific requirements.

Price: $2800.00

MDSAP Internal Auditor Training

This virtual instructor-led course was designed and developed by the Medical Device Single Audit Program (MDSAP) Lead Project Manager responsible for the team that designed, implemented, and maintained the MDSAP program.

This training focuses internal auditors on the applicable MDSAP country-specific requirements that are applicable to the auditee organization. This focus, when used in conjunction with an existing ISO 13485 internal audit program, will provide the comprehensive coverage necessary to assure all applicable MDSAP regulatory requirements are audited. In addition, resources and insight into how MDSAP Auditing Organizations establish competence of their auditors will be discussed.

An “MDSAP Lite” audit tool will be provided including country-specific requirements and hyperlinks to the specific regulatory requirements (audit criteria) relative to each country-specific requirement. Through expertly designed individual and group tasks and activities, learners will demonstrate how to identify applicable country-specific requirements, how to plan the time necessary to conduct the audit of applicable country-specific requirements, how to plan an MDSAP Lite audit, as well as how to identity, document, and grade country-specific nonconformities.

This training is essential to anyone engaged in planning or conducting internal audits of an organization participating in MDSAP.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Describe an MDSAP Audit and identify criteria used during an MDSAP Audit
  • Recognize International Medical Device Regulators Forum (IMDRF) governing procedures relative to MDSAP Auditing Organizations
  • Recognize the competency and training requirements for AO auditors
  • Recognize the structure and utility of the “MDSAP Lite” internal audit approach and “Toolkit”
  • Calculate audit time and plan an MDSAP Lite internal audit
  • Identify nonconformities, write nonconformity (NC) statements, and support the nonconformity statements with audit evidence
  • Identify post-audit MDSAP activities including NC grading
  • Recognize the outcomes and goals of an MDSAP audit

Price: $1200.00

EU IVDR Internal Auditor

This virtual instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU IVDR. This course also focuses on ISO 13485:2016 relative to its correspondence with the EU IVDR.

This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union In Vitro Diagnostic Regulation (EU IVDR).  The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning and conducting EU IVDR audits according to NSF’s formal, documented EU IVDR Audit Model.

This course includes a two-hour eLearning prerequisite module, EU IVDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key pre- and post-market requirements associated with EU IVDR – standard regulatory requirements that must be met by all In Vitro Diagnostic manufacturers wishing to do business in the EU regardless of IVD classification.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify Key Articles and Annexes of the EU IVDR
  • Recognize Intent of Requirements as Described in Recitals
  • Identify Classification Implementing and Classification Rules
  • Identify General Safety and Performance Requirements (GSPRs)
  • Recognize Content of Technical Documentation
  • Identify Post-Market Surveillance Reporting and Vigilance Obligations
  • Recognize one EU IVDR Audit Model
  • Plan an EU IVDR Audit
  • Document Nonconformities against EU IVDR requirements

Who should attend:

This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU IVDR, for managers of audit programs, and for anyone who will be the subject of or participate in an EU IVDR audit. Delegates should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.

Price: $1200.00