Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues
Instructor:
Gregory Martin
Product ID: 705347
- Duration: 90 Min
Why Should You Attend:
Data integrity is fundamental in a Pharmaceutical Quality System which ensures that medicines are of the required quality. This requires an understanding the expectations for data integrity from a CGMP perspective. Reviewing FDA guidance documents and citations in FDA warning letters will facilitate this understanding. Providing practical steps which can be taken will help your organization reduce the likelihood of receiving a Warning Letter due to Data Integrity issues.
Upon completion of this course the learner should:
- Understand what Data Integrity is, and why it is so important.
- Be familiar with regulatory expectations for laboratory notebooks and computer systems.
- Be familiar with issues that resulted in warning letters from the FDA.
- Understand some practical steps that can be taken to facilitate good documentation and reduce the likelihood of receiving a warning letter for data integrity issues.
Areas Covered in the Webinar:
- What is meant by ‘Data Integrity’?
- Data integrity expectations from the FDA guidance
- Discussion on computer systems, notebooks and spreadsheets
- FDA warning letters citing data integrity issues
- Practical steps you can take to avoid being cited
- Questions and discussion
Who Will Benefit:
- Quality Control Personnel
- R&D Scientists
- Laboratory Supervisors and Managers
- Quality Assurance Personnel
- Chemists/Managers
- Regulatory Affairs Personnel
Gregory Martin
Founder and President, Complectors Consulting LLC
Gregory Martin is President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry, including Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company to solving challenging problems. He provides consulting services to over 50 companies, including human and veterinary pharmaceutical companies, manufacturers of OTC and nutritional supplement products, and contract organizations.
In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He also serves on the Steering Committee of the AAPS IN Vitro Release and Dissolution Testing Focus Group.
He has particular interest in QbD/Lean approaches to dissolution testing, method lifecycle (development/validation/transfer), impurity testing and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is has presented at several scientific meetings, and authored of several papers in the areas of dissolution and analytical method validation.
More Training By Experts
- Lifecycle Approach to Analytical Methods with QbD Elements: Design, Development, Validation, Transfer
- Residual Solvents: Understanding the Requirements and Practical Advice for Implementing USP <467>/ICH Q3C
- Dissolution Instrument Qualification to Meet Requirements and Minimize Product OOS Dissolution Results
- 4-hr Virtual Seminar: Using the USP Effectively
- QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
