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Hands-on Training for Small Molecules, Biologics and Medical Devices

December 3-5, 2018
  • San Diego, CA

Join IVT as we embark on our Annual Laboratory Week Conference. Our 2018 programs include:

Laboratory Data Integrity
Analytical Procedures & Methods Validation
Stability Testing

Designed to maximize your time out of the office, IVT’s 6th Lab Week conference series draws over 100 laboratory professionals and provides the value of three conferences in one, giving your team the ability to select sessions that best meet your business objectives. Choose from over 25 workshops, think tanks, interactive presentations, case studies and educational courses surrounding:

  • Global regulatory trends and requirements, including the May 2018 Bioanalytical Validation guidance, March 2018 MHRA OOS Guidance and anticipated 2018 FDA Data Integrity guidance
  • Training for executing procedures that survive the lifecycle and mitigate Data Integrity risk
  • Solutions to top challenges of complying with today’s expanded FDA CDER and CDRH requirements

Plus, gain take-home solutions to your individual company needs by participating in:

FRESH SESSION FORMATS

Data Integrity Mock Inspection — Mitigating Data Integrity Risk in Analytical Methods and Stability Testing

Two experienced session facilitators and auditors involve the audience in a mock inspection.

BYOC — Bring Your Own Challenge Workshop

Practical Applications for Critical Method Validation Procedures

Office Hours

Meet one-on-one with Lab Week speaking faculty during Office Hours to gain answers and insights on your individual laboratory and method validation challenges.

Featuring Three Pre-Conference Summits

Statistics for the Non-Statistician — Foundational Reports, Concrete Tools and Practical Examples for Statistical Modeling

Raul Soto, MSc, CQE
Senior Principal Software Quality Engineer, Quality Assurance Operations
Johnson & Johnson Vision Care, Inc.

Pharmaceutical Stability Discussion Group (PSDG) Sampler — Benchmark and Poll Your Stability Practices

John O’Neill, MS, RPh
Stability Information Specialist
Nagano Science

Develop a Risk Mitigation Strategy for Lifecycle Management in the Analytical Laboratory

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharma Ltd.

FDA KEYNOTE ADDRESS

Analytical Method Lifecycle — Monitoring Method Performance

Lokesh Bhattacharyya
Chief, Laboratory of Analytical Chemistry and Blood Related Products,
Division of Biological Standards and Quality Control,
Office of Compliance and Biologics Quality, CBER
U.S. Food and Drug Administration

Previous Attendee Acclaim:

Great, enthusiastic and convincing speakers!

Supervisor, Abbott

Great opportunity to listen to Method Validation subject matter experts and network with scientists in
similar fields. Highly recommend.

Research Chemist, ECBC

Great conference for analytical chemists!

Associate Chemist II, Upsher-Smith Laboratories

IVT’s Annual Lab Week

Hands-on Training for Small Molecules, Biologics and Medical Devices

Join IVT as we embark on our Annual Laboratory Week Conference. Our 2018 programs include:

Laboratory Data Integrity
Analytical Procedures & Methods Validation
Stability Testing

Designed to maximize your time out of the office, IVT’s 6th Lab Week conference series draws over 100 laboratory professionals and provides the value of three conferences in one, giving your team the ability to select sessions that best meet your business objectives. Choose from over 25 workshops, think tanks, interactive presentations, case studies and educational courses surrounding:

  • Global regulatory trends and requirements, including the May 2018 Bioanalytical Validation guidance, March 2018 MHRA OOS Guidance and anticipated 2018 FDA Data Integrity guidance
  • Training for executing procedures that survive the lifecycle and mitigate Data Integrity risk
  • Solutions to top challenges of complying with today’s expanded FDA CDER and CDRH requirements

Plus, gain take-home solutions to your individual company needs by participating in:

FRESH SESSION FORMATS

Data Integrity Mock Inspection — Mitigating Data Integrity Risk in Analytical Methods and Stability Testing

Two experienced session facilitators and auditors involve the audience in a mock inspection.

BYOC — Bring Your Own Challenge Workshop

Practical Applications for Critical Method Validation Procedures

Office Hours

Meet one-on-one with Lab Week speaking faculty during Office Hours to gain answers and insights on your individual laboratory and method validation challenges.

Featuring Three Pre-Conference Summits

Statistics for the Non-Statistician — Foundational Reports, Concrete Tools and Practical Examples for Statistical Modeling

Raul Soto, MSc, CQE
Senior Principal Software Quality Engineer, Quality Assurance Operations
Johnson & Johnson Vision Care, Inc.

Pharmaceutical Stability Discussion Group (PSDG) Sampler — Benchmark and Poll Your Stability Practices

John O’Neill, MS, RPh
Stability Information Specialist
Nagano Science

Develop a Risk Mitigation Strategy for Lifecycle Management in the Analytical Laboratory

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharma Ltd.

FDA KEYNOTE ADDRESS

Analytical Method Lifecycle — Monitoring Method Performance

Lokesh Bhattacharyya
Chief, Laboratory of Analytical Chemistry and Blood Related Products,
Division of Biological Standards and Quality Control,
Office of Compliance and Biologics Quality, CBER
U.S. Food and Drug Administration

Previous Attendee Acclaim:

Great, enthusiastic and convincing speakers!

Supervisor, Abbott

Great opportunity to listen to Method Validation subject matter experts and network with scientists in
similar fields. Highly recommend.

Research Chemist, ECBC

Great conference for analytical chemists!

Associate Chemist II, Upsher-Smith Laboratories