4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs
Instructor:
Nanda Subbarao
Product ID: 704730
- Duration: 4 hrs
Why Should You Attend:
Data integrity related issues are currently the focus of regulatory inspections worldwide. We have seen a sharp increase in the number of warning letters from the FDA on this topic The FDA’s April 2016 draft guidance and guidances issued by other regulatory agencies have wide implications on how raw data, both electronic and paper, is to be generated, reviewed and archived. This webinar will address the key elements of regulatory expectations for data integrity.
Areas Covered in the Webinar:
9.00-10.00: Introduction to Regulatory Expectations for Data Integrity
- What are the new and evolving regulatory expectations
- What are the consequences of not meeting regulatory expectations for data integrity
- Overview of a ten step approach to achieving data integrity
- Q&A
10.00-10.05: Break
10.05-11.00: Generation, Review and Archiving Data
- Step 1: Generation of data
- Step 2: Review of data
- Step 3: Archiving data
- Step 4: Addressing OOS results
- Q&A
11.00- 11.05: Break
11.05 -12.00: Evolving Requirements for eData
- Step 5: QC instrument generated data
- Step 6: Data in LIMS systems
- Q&A
12.00- 12.05: Break
12.05 -1.00: Support Systems for Data Integrity
- Step 7: SOPs to support data integrity
- Step 8: Auditing to identify problem areas in data integrity
- Step 9: Training to support data integrity
- Step 10: Maintaining the culture
- Q&A
Who Will Benefit:
- QC chemists, supervisors and managers
- R&D chemists, supervisors and managers
- QA managers and personnel
- Regulatory affairs personnel
Nanda Subbarao
Senior Consultant, Biologics Consulting Group
Dr. Nanda Subbarao holds a Ph.D. in Bio-organic Chemistry. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from pre-clinical phase to commercial phases. She has extensive expertise in setup of cGMP/GLP complaint quality systems for laboratory and stability programs as well as upgrade of existing quality systems for products during development and in commercial phases. She is currently a senior consultant with the Biologics Consulting Group specializing in analytical, stability, CMC and GLP/GMP quality systems. She serves on the AAPS Stability Focus Group Steering Committee as well.
More Training By Experts
- Best Practices for Conducting OOS Investigations (in Pharmaceutical Laboratories)
- Designing Effective and Efficient Extractables or Leachables Studies for Biologics
- Particulates in Biological Products - Evolving Regulations for Testing in Clinical and Commercial Stages
- Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals
- Why and How - Verification of Compendial Methods - USP <1226>
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).
