LabInnovations returns to the NECon 30 & 31October 2019

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Related stories

Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

State of API & Peptide CDMO Capacity

Pharmaceutical companies planning peptide or complex small-molecule launches are...

What Goes Into Synthetic Urine? The Chemistry Behind Replicating a Biological Fluid

Synthetic urine sounds simple until you look closely at...
- Advertisement -

More than 150 leading scientific suppliers and 3,000 attendees will descend on Lab Innovationson 30& 31October2019 at the NEC,Birmingham,to  discover,  debate  and  discuss  the  latest  scientific  developments  and equipment.

Now  in  its 8thyear, the UK’s only trade  show dedicated  to  the  laboratory industry continues to enjoy support from some of the UK’s leading scientific institutions and will this year boast its largest ever exhibitor and visitor base, providing more exciting product launches, innovation and discussion than ever before.

Analytix, Anton  Paar,  Cole-Palmer,  Eppendorf, GAMBICA, IKA, Perkin  Elmer,  SLS, Shimadzu and Thermo Fisher Scientificare among the big industry players participating for 2019. Joining them will be a further +150 suppliers and manufacturer spresenting the  most  cutting-edge  equipment  applicable  to a plethora of  industries  including  life sciences, pharmaceuticals,petrochemicals, materials science and food and drink.


“GAMBICA has exhibited at Lab Innovations since the start. We find it oneof the most effective events for connecting our members with purchasers and distributors.”Commented Jacqueline Balian, Head of Laboratory Technology Sector, GAMBICA.

Lab  Innovations will this  year be  celebrating  2019  as  the  International  Year  of  the Periodic  Table,  with  the  Royal  Society  of  Chemistry focusing  on  this  the mein  their dedicated  theatre and  several  related  networking  events  taking  place  across  the  two days.The  Perkin  Elmer-sponsored  “Insights  and  Innovations”  theatre  will  once  again  beorganised  by  UK magazine Laboratory  News and  will  provide  insight  into  the  latest discoveries and discuss best-practices and day-to-day challenges.

For  cleanroom  specialists,  the  Clean room  Hub,  in  collaboration  with  Cleanroom Technology, will provide a dedicated zonefor suppliers of cleanroom-specific equipment. Itincorporates  a seminar  pod with  2  days  of  educational  content  for  cleanroom professionals, a networking lounge and dedicated exhibitor pavilion. With a clear demand for  this  type  of  content  at  Lab  Innovations  following  a  68%  increase  in  cleanroom attendees in 2018, this zone is set to create another buzz at this year’s edition.First-time exhibitors at Lab Innovations will showcase new products in the adjacent “Lab News Village”,where they will display products that have never been seen before at the event. Additionally, the well-received SLS pavilion will expand for its second appearance at  Lab  Innovations,  providing  an  opportunity  for  20 partners  of the UK’s  largest independent   supplier   of laboratory   equipment,   chemicals   and   consumables   to participate.

With sustainability high on the UK agenda and an increased demand for practical advice and  solutions  in  this  area, the ‘Sustainable Laboratory’ will return for  2019.  This  will provide an opportunity for attendees to speak with leading UK universities on how they made use of ‘green’ equipment and processes to achieve sustainable results.Carolyn Jones, Lab Manager at the University of Birmingham commented on her success with finding sustainability solutions at last year’s event:“I’m very interested in the sustainability side of things and looking at what people are doing to reduce their carbon footprint. It’s good to see all equipment out and working on the stands, from all the big companies  as  well  as  smaller  start-up companies. It’s been a good day out and well worth attending.”

New for 2019 is a bespoke meetings concierge service, providing visitors and exhibitors with  the  opportunity  to  pre-arrange  meaningful  meetings  with  exactly  the  companies and attendees they want to discover and do business with. This exciting new initiative will  accentuate  the  event’s  position  as  the  leading  meeting  place  for  Laboratory professionals and suppliers.Phil Ellis, Equipment Services Manager, Aberystwyth Innovation and Enterprise Campus Ltd summed up his first visit and the importance of making connections: “This is the first time I have attended Lab Innovations and I have ended up coming both days due to the amount of connections we were making. Besides networking, Lab Innovations has given me the opportunity to keep up-to-date as the entire market is here. I will definitely come again.”

MEDIA RELEASE New for 2019 is a bespoke meetings concierge service, providing visitors and exhibitors with  the  opportunity  to  pre-arrange  meaningful  meetings  with  exactly  the  companies and attendees they want to discover and do business with. This exciting new initiative will  accentuate  the  event’s  position  as  the  leading  meeting  place  for  Laboratory professionals and suppliers.Phil Ellis, Equipment Services Manager, Aberystwyth Innovation and Enterprise Campus Ltd summed up his first visit and the importance of making connections: “This is the first time I have attended Lab Innovations and I have ended up coming both days due to the amount of connections we were making. Besides networking, Lab Innovations has given me the opportunity to keep up-to-date as the entire market is here.

I will definitely come again.”The  Lab  Innovations  Advisory  Board will meet  later  this  month  to  discuss  furtherthe details of the conference topics and the shape of the event.Gerald Law, CEO Innovation DB, member of the Lab Innovations advisory board saysthat:“The advisory board comes together a couple of times a year to define the direction of the annual event. This year the agenda will feature laboratory automation and informatics, the recruitment of young talent  into  STEM, the  implications  of  Brexit, of  course  sustainability,  and  a  lot  more. Watch this space for further announcements!”

Save the date: 30 & 31 October 2019, NEC, Birmingham

About Easyfairs Easyfairs enables communities to “visit the future” at must-attend events that anticipate their needs and present solutions in the ideal format. The group currently organises 218 events in 17 countries (Algeria, Belgium, China, Denmark, Emirates, Finland, France, Germany, the Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, the United Kingdom and the United States). Easyfairs also manages 10 events venues in the Benelux, Netherlands and Nordic region (Ghent, Antwerp, Namur, Mechelen-Brussels North, Hardenberg, Gorinchem, Venray, Stockholm, Gothenburg and Malmö). The group employs more than 750 people and generated revenues exceeding €160 million for its financial year 2016-2017. Easyfairs strives to be the most adaptable, agile and effective player in the events industry by employing committed individuals, deploying the best marketing and technology tools and developing strong brands. Visit the future with Easyfairs. For more information, please visit www.easyfairs.com

Never miss a pharmaceutical headline

The pharmaceutical industry moves fast – stay on top of it with our must - read briefings.

  • The top pharma and life sciences stories, straight to your inbox
  • The biggest news, features, interviews, and analysis
  • Dedicated coverage of the key developments driving the global pharmaceutical sector

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Latest stories

Related stories

Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

State of API & Peptide CDMO Capacity

Pharmaceutical companies planning peptide or complex small-molecule launches are...

What Goes Into Synthetic Urine? The Chemistry Behind Replicating a Biological Fluid

Synthetic urine sounds simple until you look closely at...

Danaher Prepares to Introduce Advanced AI-Powered Laboratory

In a significant step for pharmaceutical research, Danaher has...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access theMedia Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Translate »