Three interactive modules that tackle the requirements and the discipline needed to consistently manually document and electronically record the manufacturing & testing of APIs, Drug Formulations, Biosimilars and Vaccines:
DATA INTEGRITY MEANS
Manual Entries: “If you didn’t write it down per ALCOA…
Electronic Transactions: “If it wasn’t validated per Part 11 with intact audit trails…
it didn’t happen”
- FDA / EMA: Expectations for Data Integrity Ethics, Law and Transparency
- Data Integrity Reality: Detect; Panic; Investigate; Report and Repair
- Documentation Best Practices
- Electronic Data Governance in the GMP Environment
- Regulatory Expectations and Laws regarding Data Integrity and Electronic Data Governance
- How to handle Data Integrity challenges of detection, investigation, regulatory response and CAPA
- Case Studies that describe real life examples of how companies have handled Data Integrity Issues and how the regulators reacted
- Best Practices for creating GMP appropriate Documentation
- How to encourage GMP Documentation discipline on the shop floor, warehouse and labs
- How the interactive role of the quality systems and plant management can bring about a culture of good GMP documentation
- Electronic Data Governance: Regulatory expectations; what documents / policies / procedures should be in place; how to define the GMP boundaries around automated systems; role of Quality Assurance with automated systems; what to do and how to investigate if there are electronic data integrity problems.
Who will Benefit:
- QA Personnel
- IPQA Personnel
- QC Personnel
- Manufacturing Personnel
- Warehouse / Material Management Personnel
- GMP Management Personnel
- R&D Personnel involved with Tech Transfer
- GMP API Personnel
- Non-GMP Intermediates Personnel
- CRAMS Personnel
- HR Personnel
Early bird seats are limited and based on first-come, first-serve.
Your registration fee includes the workshop, all course materials and lunch.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.
Send Your Team for Maximum Benefit Get your team up to speed!
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
- 2 Attendees
- 3 to 6 Attendees
- 7 to 10 Attendees
- 10+ Attendees
Call Toll Free +1-1-888-771-6965 if you have any queries.
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Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2479 East Bayshore Road, Suite 260
Palo Alto, CA 94303
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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ email@example.com
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
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After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
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