Session Length: Full Day
Open Session dates: September 12, 2018
Pricing: $950 per participant
Integrity 2.0: Managing Your GxP Data Program
Full-day interactive training
This course will reinforce your understanding of Data Integrity principles, and explain how to implement a compliant data quality program. The course addresses data used to make or support decisions that impact patient wellness and product quality and considers recent 2018 Health Canada guidance changes that mandate a data governance program.
This course will:
- Review Data Integrity requirements embedded into the new 2018 GMPs
- Clarify how other data guidances fit in
- Review the specific data integrity expectations for systems of manufacturing, storage, distribution, quality control, and laboratories
- Examine the impact of data integrity on your operations and supply chain
- Explain the impact for your regulatory affairs, product registration, and facility licensing
- Evaluate the impact of data integrity on key quality system metrics
- Fulfill the Health Canada requirement for initial and continuing GMP training
- Transform data integrity from laboratory-specific to company-wide governance
- Evaluate the current industry trends toward cloud-based and AI (artificial intelligence) processes
- Explain what Data Integrity (DI) is
- Communicate/explain DI expectations to other business partners
- Identify areas of high risk to your patients and products
- Assess potential risks in your supply chain and operations
- Develop compliance action plans
Who Should Attend
- Currently works in a GxP environment that must meet regulatory requirements for computerized systems
- Manages computerized systems (e.g., maintenance, system planned/unplanned changes)
- Manages quality systems/practices using computerized systems (e.g., electronic disposition, change controls, etc.)
- Conducts or audits self-inspection programs
- Validates computerized systems for their intended GMP use and/or supports computer system validation activities either directly or indirectly
- Designs or implements electronic systems intended for GMP use
- Reviews and/or approves electronic records
Large Drug Wholesaler Questioned by Health Canada
In February 2018, prior to Health Canada posting the new 2018 GMPs, Q&C hosted the Health Canada inspection of a large pharmaceutical wholesaler. The Health Canada inspector spent a considerable amount of the audit focusing on the lack of warehouse management system WMS validation and data integrity. This was surprising, as it was the first time we had seen this expected for a Wholesaler. When the new GMPs were posted in the following weeks we saw that this was expressly addressed in Records. We are expecting a strong audit focus on the all the new requirements, despite the new GMPs having an effective date of October 1, 2018.
Major Research and Testing Client Challenged by FDA
FDA challenged client on data integrity provisions and threatened an FDA 483. Q&C co-hosted the FDA audit with the client and persuaded FDA that a revised plan and progress to that plan would address FDA requirements. No FDA 483 was received.
Contract manufacturer Needed Data Integrity Program Prior to Health Canada audit
A leading cGMP contract service provider of integrated chemistry, drug discovery, development and manufacturing services to pharmaceutical and biotechnology industries was informed they would be audited by Health Canada. Q&C worked with the client to implement a data integrity governance system. The Health Canada audit went smoothly and resulted in no findings.
I recently attended a Q&C training session on data integrity, and found it was very informative, well organized, and easy to understand. The presenter knew the complex subject well and kept us engaged. Interactive exercises and practical examples helped me absorb this detailed subject and showed me how to apply the course content in my job.
Why Train with Q&C?
- Interactive sessions
- Expert consultant trainers with hands-on industry experience
- Course certificate to fulfill Health Canada’s annual GMP training requirement
- We wrote the book on compliance…literally. Over 150,000 Blue Books have been published and used worldwide since 2002
- Q&C has 25 years regulatory and compliance experience and we specialize in Health Canada remediations
- We host at least one Health Canada audit each month and perform over 30 self-inspections annually
Sign up for our interactive training seminar September 12, 2018
$950 per participant