Pharmaceutical Data Integrity Success Training Kit - Pack of 8 Training Courses

recorded version

$1,299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD / USB Drive

$1,499.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Based on 8 webinars presented by experts with hands-on industry experience in both pharmaceutical and medical device manufacturing operations

Order this data integrity training kit to achieve compliance with regulators’ expectations without committing a disproportionate amount of human or financial resources.

You hear it all the time: companies receiving warning letters and being scrutinized for data integrity. They think they have taken all measures for data integrity and hope there are no issues.

Many of these companies - wish and hope, but still, run into data integrity issues.

Without the right understanding, proper controls, and tools, even your best efforts can go awry. On the other hand, when you have the right understanding of how to achieve data integrity and implement the right measures, you achieve data integrity and compliance.

Our comprehensive "Pharmaceutical Data Integrity Success Training Kit" contains everything you need to guarantee data integrity success. It's the culmination of 50 plus years of combined experience packaged into one training kit we could share with you, and you can order your kit right now!

All Modules:

Module 1: Pharmaceutical Data Integrity
Module 2: Implementing a Robust Data Integrity Program
Module 3: How to Detect Lack of Data Integrity
Module 4: Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues
Module 5: Implementation and Management of GMP Data Integrity
Module 6: Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience
Module 7: Advanced Auditing for Data Integrity
Module 8: Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

Part 1 : Pharmaceutical Data Integrity
Instructor: Mark Powell

Areas Covered in the Webinar:

  • Data integrity myths
  • Historical background
  • Definition of data integrity
  • Current regulatory approach
    • Guidance
    • Static and dynamic records
    • Non-conformance trends
    • Example enforcement letters
  • Data integrity risks in the analytical process
  • Conducting a data integrity risk assessment
  • Common causes of data integrity breaches
  • Practical tips on achieving compliance

Part 2 : Implementing a Robust Data Integrity Program
Instructor: Kelly Thomas

Areas Covered in the Webinar:

  • Topic 1: Regulatory Guidance Review
    • FDA (CFR)
    • EU (EurdraLex)
    • PIC/S
    Read more

Part 3 : How to Detect Lack of Data Integrity
Instructor: Ron Snee

Areas Covered in the Webinar:

  • What is data integrity; what does it look like
  • Case studies illustrating types and sources of data integrity issues
  • Procedures for assessing data pedigree, integrity and quality
  • Data Pedigree – A New Tool for Assessing the Level of Data Integrity
  • Computer, analytical and statistical methods for evaluating data integrity and quality
  • Limitations of observational data
  • Guiding principles, tips and traps for the effective data integrity assessment

Part 4 : Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues
Instructor: Gregory Martin

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

Part 5 : Implementation and Management of GMP Data Integrity
Instructor: Danielle DeLucy

Areas Covered in the Webinar:

  • Understand the current regulatory position on data integrity
  • Discover the criteria for data integrity
  • Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
  • Learn about approaches to improve data integrity in a laboratory environment
  • Part 11 compliance
  • FDA citations related to data integrity issues

Part 6 : Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience
Instructor: John R Godshalk

Areas Covered in the Webinar:

  • What is data integrity?
  • What are the relevant regulations for data integrity?
  • Why record data and create records?
  • What is the interaction with software and data integrity?
  • What documentation/evidence does FDA look for during an inspection with regard to data integrity?
  • Examples of Data Integrity issues: data integrity and the pre-approval inspection, data integrity in the lab, data integrity in the batch record, computer systems, data falsification, importance of audits
  • Summary/ Q&A

Part 7 : Advanced Auditing for Data Integrity
Instructor: Joy McElroy

Areas Covered in the Webinar:

  • Applying consistent meta tags to all documents
  • Applying consistent policies to all records
  • Achieving a best practice level of compliance
  • Centralizing management and eliminating silos
  • Reduce compliance and e-discovery risks
  • Building a better business case

Part 8 : Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues
Instructor: Gregory Martin

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
Follow us :
Raw Material Requirements
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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