Digitalisation of the Quality Management System of Pharma Regulated Laboratories

Quintessence Enterprises Ltd and Dr Bob McDowall of R D McDowall Limited, UK
An internationally known trainer and writer will present the training Course
Digitalisation of the Quality Management System of Pharma Regulated Laboratories, as two-day HRDA training program of High Importance.

The course is being delivered οn May 08 & 09, 2023.

After the completion of the program the half-day visits to the participating companies will take place a couple of days later.

Program code

PHARMA 2

Program numbering

2320701

Duration

14h the seminar plus

4h the visits

Dates:

08th & 09th of May 2023

Venue:

Total Fee: €1600,00 + VAT

HRDA subsidy: €1.530,00

Net cost: €70,00

More than 3 participants: €600+VAT

Non HRDA beneficiaries cost: €900+VAT

The aim
of
this program

Why should you attend this program?

A subset of Pharma 4.0, a framework for adapting digital strategies to the unique contexts of  pharmaceutical manufacturing, is Lab 4.0 or the digitalization of GMP-regulated pharmaceutical laboratories to ensure efficient and effective working and quicker product release to the market.
This practical course consisting of presentations, workshops and discussions provide an in-depth understanding of how to approach Lab 4.0 including:
• Developing a strategy for digitalization
• Mapping and redesigning processes for automation
• Managing both project and regulatory risk
• Digitizing the data and bringing clarifications on regulatory & business risks as well as the automation examples from the Pharma laboratory environment.

It will focus as well on effective computerized systems validation and IT infrastructure qualification & support.

Participants will learn about the options to integrate the system and maintain it, including change control.

The training
needs

Why did we design this program?

The need for digitalization in pharmaceutical laboratories is continuously evolving & there is a need for a more unified approach to laboratory and data management. Leading pharmaceutical and biotech companies are re-assessing the processes and digital tools (incl. information systems)
they use to collect, handle and organize QC laboratory data.
In practical terms, Pharma 4.0 means more connectivity, more productivity, simplified compliance, and the marshaling of production information to respond to problems as they emerge.

The Pharma 4.0 mission statement is “[To] Manufacture pharmaceutical products with maximum product and process understanding, data integrity by design, efficiency and optimal resource allocation on the basis of full digital data transparency–to the benefit of the patient.”

To this end, there are six stages of digital maturity: Computerization, Connectivity, Visibility, Transparency, Predictability, adaptability. This practical course provides an in-depth understanding of redesigning processes to automate & digitize them and brings clarifications on  regulatory & business risks as well as the automation examples from Pharma  laboratory environment. It will focus as well on effective computerised systems validation and IT  infrastructure qualification & support.

Participants will learn about the options to integrate the system and maintain it, including change control.

They will enhance their digital laboratory automation journey to achieve greater innovation, collaboration & productivity.

Who should attend?

The course addresses the QC Analysts e.g. analytical chemists, pharmacists, regulatory personnel,
pharmacopeia specialists.
More specifically, personnel involved in:
• Managers and scientists from Quality Control and Analytical Development Laboratories wanting
to understand the digilization of data
• Quality Assurance personnel providing digital GMP data
• Contract Research Organization and Contract Manufacturing Organization laboratory and QA
personnel
• Auditors (internal and external) responsible for assessing laboratory quality and data integrity

Course Facilitator

Who motivates you develop new knowledge?

Bob MacDowall

Pharmaceutical Consultant.

Learning
Outcomes

How you Will transform your cognitive profile?

Participants will be able to:

Knowledge

K1. Identify the digitalization of data and data integrity requirements of a GMP-regulated laboratory in Pharmaceutical organizations and contract labs
Reveal current regulatory citations driving automation and elimination of paper

K2. Ensure compliance with the EU and FDA Good Manufacturing Practice Regulations Impacting Laboratory Data and Results

K3. Gain the principles of laboratory automation to ensure business efficiency and regulatory compliance

K4. Evaluate the current laboratory system

K5. Manage regulatory & business risks

K6. Develop effective & efficient computerized systems

K7. Reveal critical insigths into IT infrastructure support & qualification

K8. Utilize records generated by (1) Paper (records maintained in a laboratory notebook or controlled sheets), (2) Hybrid Systems (signed paper records with underlying electronic records) and (3) Electronic Systems incl. ELNs (an electronic system using electronic signatures)

Skills

S1. Redesign the laboratory processes and data logging

S2. Develop a Digitalization Strategy

S3. Validate the computerized systems

S4. Support the IT infrastructure

S5. Maintain the laboratory digitalized environment

S6. Manage throughout the system life cycle

Attitudes

A1. Integrate the laboratory data within the digitalized laboratory environment

A2. Prioritize the areas within a pharmaceutical quality system to focus on when conducting a data integrity audit.

A3. Adapt laboratory processes to the digital laboratory environment

A4. Explore the examples of automation

A5. Gain insights into practical change control and configuration management

Course
content

Which are the new cognitive subjects?

Day 1
Introduction & speed networking
Introduction to the Course
• Topics covered over the two days
• Drivers for change: understanding the c in cGMP
• What do we call this: paperless, less paper, automation, electronic working, digitization?
• How the interactive workshops will be organized and run
• Outputs from the workshops will be available after the course
• Discussion sessions
Developing a Laboratory Automation/Digitization Strategy
• Business benefits drive or regulatory requirements push? Current regulatory citations driving automation and elimination of paper
• Develop a Laboratory Automation Strategy
• You can’t automate the whole laboratory at once, it will take time
• Where are you now?
• Where do you want to be?
• Top down or bottom-up approach to automation?
• Use application convergence to your advantage
• Three principles of laboratory automation to ensure business efficiency and regulatory compliance
• How to get there?
• Configuration versus customization of software
• Senior Management support and resources are critical for success
• The first project is critical to ensure user buy-in and demonstrate benefits of the strategy

Process, Process, Process
• The key to digitization success is to understand your current process and design activities to work electronically
• Map the current process: identify inefficiencies
• Design the new process
• Prototype the application to refine the process and user requirements
• Interactive Workshop
Attendees will be given a process to analyse – interactive feedback of comments
• Redesign the process to automate and digitize the process

Managing Business and Regulatory Risk
• Annex 11 clause 1 requires risk management throughout the system life cycle
• Project risk management and regulatory risk management
• Purchasing the system: are you perpetuating the data integrity problem?
• Is your company’s computer validation procedures fixed or flexible?
• Installation options: On-premises, Infrastructure as a Service (IaaS) or Software as a Service (SaaS)?
• Working with a supplier to improve your processes and their software
• Leveraging a supplier’s software development to reduce your validation work
• Facilitated Discussion / Case Study: How would you conduct a Supplier Assessment to reduce your validation effort?

Automation Examples and Mini Workshops
• This session will feature a number of case study examples of automation examples and miniworkshops
• Mini-workshops will involve
• Presentation of a scenario to attendees to suggest options for automation
• Feedback by the trainer followed by discussion

Day 2

Effective and Efficient  Computerised System Validation (CSV) and Analytical Instrument Qualification (AIQ)
• CSV is a fact of life in regulated pharma laboratories
• Is CSV a business benefit or a regulatory burden?
• Integrated analytical instrument qualification (AIQ) and computerised system validation (CSV)
• Flexible approaches to CSV to ensure business efficiency, regulatory compliance and data integrity
• Avoiding CSV pitfalls to make validation efficient
• Workshop: How would you approach these qualification / validation situations?

IT Infrastructure Qualification and Support
• Any digitization programme must have a stable IT infrastructure with effective support to ensure that the laboratory can operate efficiently without
interruption.
• What is required?
• IT infrastructure qualification: what to do and what not to do
• Time synchronization and time/date stamps
• User account management: avoiding conflicts of interest
• Cybersecurity
• Backup, recovery and archive
• Disaster recovery and business continuity planning

Integrating Systems to Leverage Further Business Benefits
• Networked system can automate a process efficiently but to leverage benefits for the laboratory systems should be interfaced together
• Options for integrating systems e.g. instruments to instrument data systems, instruments to LIMS, LIMS to LES and LIMS to ERP systems
• Workshop: Scenarios for attendees to determine interfacing options

Maintaining the System
• Regulatory requirements for change control
• Current pharma industry approaches: its validated – don’t touch it!
• Business v IT v QA for change control
• Change issues with On-premises versus SaaS installations
• Practical change control and configuration management
• Workshop: given examples of changes to
computerised systems

DISCUSSION / QUESTION AND ANSWER SESSION

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