Contact us

GMP for Biological and Biotechnology Products Training

Dates

Times

4 days16 hrs VILT, 6 hrs self-paced

Location

Virtual Learning

Availability

About This Course

This course details the rules and interpretation of GMP for biopharma products and discusses issues and challenges with seasoned NSF experts.

The course provides insights on how to interpret and deploy the requirements of both the U.S. cGMP and EudraLex Volume 4 (particularly Annex 2). It covers the cGMP requirements for each key process step especially concerning process development, validation, control, auditing, effective quality assurance (QA) and quality control (QC).

This course is offered virtually and the 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.

Course Outline

This biotech course includes:

  • The key design, controls and monitors associated with the common biotech process steps
  • The basic science and typical process controls associated with producing a high quality biological or biotech drug substance
  • An introduction to how quality is assured across the bioprocess and the insights/limitation of QC testing
  • A summary of hot topics including regulatory censure, GMP observations and trends
  • Guidance on the key concerns when acting as an EU QP or QA/production/technical services professional in this field

We explain the critical requirements of cGMPs alongside a range of bioprocesses, including:

  • Seed/cell banking
  • Serial and bulk cultivation
  • Harvesting
  • Centrifugation
  • Viral inactivation
  • Chromatography
  • Ultrafiltration
  • Protein concentration

The course also includes sessions associated with:

  • A contrast in U.S. and EU cGMP regulation and enforcement
  • Effective design and monitoring of bio facilities and their utilities
  • Cleaning verification and validation
  • Best practices when manufacturing advanced therapy medicinal products (ATMPs)
  • Developing a QC strategy for biomolecular characterization
  • How to audit bioprocessing facilities, manage risk and investigation of common process deviations

Want more? We have three hours of additional self-paced material that covers:

  • Specific issues for cold chain management of biomolecules
  • Common concerns when formulating and filling bio drug products
  • Microbial contamination control during bioprocessing

Key Learning Objectives

On completion of this course, delegates will know and understand:

  • The common stages in the mammalian and bacterial bioproduction processes
  • How to verify the effectiveness of each bioprocess stage via online and offline monitoring and testing
  • The critical challenges associated with bioprocessing in terms of vulnerability, risk assessment and process control
  • How to design the pharma quality system around the requirements of the biomolecule

Our biotech training helps delegates learn how to:

  • Identify the key differences in bioprocessing compared to chemical synthesis of small molecule drug substances
  • Feel confident in making the right decisions at the right time with the right information when faced with the common challenges or GMP deviations associated with bioprocessing of drug substances
  • Identify what should appear in batch documentation associated with the key bioprocessing steps
  • Generate a risk-based, targeted audit agenda, and be aware of the requirements in the EudraLex GMP Volume 4, Annex 2
  • Delegates also become better equipped at adding value to commissioning, qualification, validation, production, operational QA and GMP auditing on-site and across fragmented global supply chains

Who Should Attend

Attend this biotech training course if you work in operations, QA, QC, technical services or are a trainee/practicing Qualified Person, especially if you are looking to broaden your knowledge in the field or make a career transition into bioprocessing.

Course Tutors

Robert Smith - Robert has more than 30 years’ experience in the pharmaceutical industry, in various production and quality roles for a number of major international pharmaceutical organizations. He is eligible to act as a Qualified Person under the permanent provisions for both commercial and investigational medicinal products. He is a QP assessor and Vice Chair of the Royal Pharmaceutical Society Panel of Assessors. Robert has broad experience in QA and manufacturing management gained through working with a wide range of dosage forms for both commercial and clinical supply, including solids, liquids, sterile products, vaccines, biological, biotechnology, viral vectors, gene therapy and cellular therapy products.

Ian White – Ian has broad experience of the pharmaceutical industry. Most recently he worked as an Expert GMDP Inspector for the UK competent authority, the MHRA, where he was responsible for developing and implementing technical and policy-based aspects of the Inspectorate work, to reduce risk and improve the quality of medicinal products for patients. He led deployment-based operations for the roll-out of COVID vaccines, therapeutics, and anti-viral medicines, working across both government and industry to ensure robust supply chains, develop policy and provide sound, pragmatic, quality risk-based guidance.

Discounts

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

  • Given me much greater insight into GMP regulations/requirements. Excellent structure to course. Brilliantly delivered.
    Alistair Brown
    Immunocore
  • John and Roger were excellent. The best part was the willingness of the presenters to make themselves available for questions and future conversations.
    Donna Foti
    Catalent Pharma Solutions
  • Excellent course content and structure, especially the deep dive into the individual process steps and definition of upstream/downstream processing, critical parameters and quality attributes. The auditing exercise for the two processing was also very insightful.
    Chantel Ellul
    Azure Pharma

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