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  • Day One: Morning Session
  • Day One: Lunchtime Session
  • Day One: Afternoon Session
  • Day Two: Morning Session
  • Day Two: Lunchtime Session
  • Day Two: Afternoon Session
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Data Integrity 2023: A Virtual Symposium

This event is now available on-demand!



Register for the event to gain free access to all sessions.
Event overview

To ensure that your data integrity programs work, it is essential to keep up to date with current regulatory trends—monitoring both new regulatory guidance documents and trends in non-compliance. In this interactive event, we will ensure that you understand the impact of recent and proposed updates, by addressing four topics:
  1. An update on Proposed Regulations for Computerized Systems and Updated FDA Guides
  2. Analytical Procedure Lifecycle: How do the draft versions of ICH Q2(R2) and Q14 compare with USP <1220>?
  3. Where is USP <1058> on Analytical Instrument Qualification going now?
  4. Computer Software Assurance (CSA) versus Computerized System Validation (CSV)
These topics will be discussed within the framework of the data integrity model that sits within the overall pharmaceutical quality system of a regulated laboratory. Analysis takes place at Level 3 in this model, but to ensure both data quality and integrity it is imperative that the elements of the Foundation and Levels 1 and 2 are in place. The analogy of this model is building a house: It collapses if not built correctly.

We will tackle one topic per session. Each session will start with a presentation, which will include a question-and-answer period. This will be followed by an interactive workshop to reinforce the principles of each subject presented. For the workshop portions, participants will be asked to engage in answering questions and sharing ideas—fully anonymously—using a free web-based platform called Mentimeter (menti.com), which can be used through a web browser on any computer or phone. No download or prior preparation is required; the link and a code will be provided during the event.

This virtual symposium on data integrity is aimed at chromatographers and quality assurance professionals who have a working knowledge of data integrity within a regulated GXP laboratory. Thus, basic knowledge, such as an understanding of GMP regulations and ALCOA+ criteria, will be assumed.

Top Reasons to Attend
  • Get up to date with current regulatory trends in data integrity
  • Understand proposed regulations for computerized systems and updated FDA guidelines
  • Learn how the draft versions of ICH Q2(R2) and Q14 compare with USP <1220> regarding the Analytical Procedure Lifecycle
  • Find out where USP <1058> on Analytical Instrument Qualification is heading now
  • Understand the differences between Computer Software Assurance (CSA) and Computerized System Validation (CSV)—and why you should care
  • Learn from interactive workshops to strengthen your understanding of these essential concepts in data integrity and how to spot and resolve problems.

Who Should Attend

 
Chromatographers from Analytical Development and Quality Control Departments along with Quality Assurance personnel who are involved in data integrity and computer validation projects. Attendees should have a working knowledge of data integrity principles and GMP regulations.

 

Session Details 

Day One, Monday, March 13, 2023 
  
Morning Session, 10:00 am–12:15 pm EST 
An Update on New Regulatory Guidance Documents and Recent Regulatory Citations

10:00–11:00 EST:            Update on Proposed Regulations for Computerized Systems and FDA Guidelines
Bob McDowall

The session will include a live question-and-answer (Q&amp;A) period.

11:15 am–12:15 pm EST: Interactive Workshop: How Are You Going to Prevent or Solve This Mess?
Bob McDowall 
 
The outputs of the session will be made available for free download after the training. The session will also include a live question-and-answer (Q&amp;A) period

Lunchtime Session, 12:30 am–1:15 pm EST
Data Integrity Tools, Tips and Best Practices from Our Sponsors 


12:30pm-12:50pm EST     Carrying Data Integrity into Electronic Records
Crystal Welch

12:50pm - 1:30pm EST      In Silico Tools for Streamlined Development and Optimization of Tandem-Column and Two-Dimensional LC Methods
Imad Haider Ahmad
  

Afternoon Session, 2:00–4:30 pm EST 
Comparison of United States Pharmacopeia General Chapter <1220> with the draft ICH Q2(R2) and Q14 for Analytical procedure Lifecycle Management  
  
2:00–3:00 pm EST           Analytical Procedure Lifecycle: How do the draft versions of ICH Q2(R2) and Q14 compare with USP <1220>?
Chris Burgess 
  
The session will include a live question-and-answer (Q&amp;A) period.

3:30-4:30 pm EST            Interactive Workshop: Implementation of USP <1220> — Challenges and Opportunities
Chris Burgess
 
The session will include a live question-and-answer (Q&amp;A) period.



Day Two, Tuesday, March 14, 2023

Morning Session, 10:00 am–12:15 pm EST
Update on USP <1058> 

10:00–11:00 am EST:      Where is USP <1058> on Analytical Instrument Qualification going now?
Chris Burgess
  
The session will include a live question-and-answer (Q&amp;A) period.

11:15 am–12:15 pm EST:    Interactive Workshop: Analytical Procedure Transfer — What Should You Do to Ensure Success?
Chris Burgess 

The outputs of the session will be made available for free download after the training. The session will also include a live question-and-answer (Q&amp;A) period.

 
Lunchtime Session, 12:30 am–1:15 pm EST 
Data Integrity Tools, Tips and Best Practices from Our Sponsors 

12:30pm - 1:05pm EST    Data Integrity and Connectivity for Lab Balances
Sebastian Weber
  

Afternoon Session, 2:00–4:30 pm EST 
Putting What’s Wrong with CSV Right 

2:00–3:00 pm EST:          Computer Software Assurance (CSA) versus Computerized System Validation (CSV)
Bob McDowall 
 
The session will include a live question-and-answer (Q&amp;A) period.

3:30–4:30 pm EST:          Interactive Workshop: How Would You Validate This System?  
Bob McDowall 
 
Attendees will be members of a CDS validation team and will be presented with a series of CDS user requirements. Will you test these requirements? If so, how extensively will you do this and how will you justify your approach? If you don’t test a requirement, how will you justify this to an inspector or auditor? How will the conservative nature of your QA department impact your approach? How will IT impact your validation approach?

Attendees will be asked to participate actively in providing inputs for each of three questions using the free web-based platform Mentimeter (menti.com), which can be used through a web browser on any computer or phone (no download required). The outputs of the session will be made available for free download after the training. 

The session will also include a live question-and-answer (Q&amp;A) period.


Featured Speakers

Chris Burgess is an analytical scientist with more than 48 years of experience in the pharmaceutical industry, initially with Glaxo in Analytical R&amp;D, Quality Control, and Quality Assurance, and then in international consultancy. He is a “Qualified Person” in the European Union. He was appointed to the United States Pharmacopoeia’s Council of Experts 2010 to 2015 and re-elected for 2015 to 2020 and 2020 to 2025. He is currently the chair of the USP Joint Sub Committee for the revision of chapter <1058>. He was also a member of the USP Expert Panel on Validation and Verification which generated General Chapter <1220>. He is a visiting Professor at the University of Strathclyde in the Strathclyde Institute of Pharmaceutical and Biomedical Sciences and an editorial board member for Pharmaceutical Technology Europe for whom writes the “Statistical Solutions” column.

Bob McDowall, RD McDowall Ltd, UK
Bob McDowall is an analytical chemist with 50 years of experience, including working in the pharmaceutical industry for 15 years and then working for the industry as a consultant for 29 years. Bob has been involved with the validation of computerized systems for more than 35 years and is the author of a book on the validation of chromatography data systems. His latest book is Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories, published in 2019 by the Royal Society of Chemistry. He is a member of the GAMP Data Integrity Special Interest Group, contributing to the Records and Data Integrity Guide in 2017 and two Good Practice Guides. Bob is also the author of the “Questions of Quality” and “Focus on Quality” columns in LCGC Europe and Spectroscopy magazines, respectively.

For any technical questions please contact Jorge de la Bandera: jdelabandera@mjhlifesciences.com