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 MEANSManual 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:
Warehouse / Material Management Personnel
GMP Management Personnel
R&D Personnel involved with Tech Transfer
GMP API Personnel
Non-GMP Intermediates Personnel
CRO / CRAMS Personnel
Warford ReaneyConsultant and Mentor
Mr. Reaney has over thirty years' experience in building, developing and managing teams to solve complex technical, compliance and business challenges. His has served in Executive and Quality Management from small technical start-ups to multi-national enterprises. Years of direct hands on involvement provide specific abilities to assist biopharma companies who serve or are entering the US/EU markets to achieve their technical, quality, product and financial goals. His frequent interaction with the USFDA enables him to assist manufacturers to meet the most current regulatory expectations.
Mr. Reaney is successful at mentoring and assisting companies to implement a program to continuously detect and over time develop a culture of accountability that eradicates data integrity problems and puts in place a sustaining and measurable way to tie Continuous Improvement with Personal Motivation.
He is immediately able to engage local teams to improve their knowledge and application for effective investigation & CAPA efforts. An acknowledged expert in CAPA system & team development for rapid compliance and internal process cultural change and long-term efficacy documentation.
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Note: Use coupon code REFERRAL10 > and get 10% off on registration.