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Basic Requirements for IQ, OQ and PQ Protocols
Kenneth Christie
Product Id: 704591
This training program will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. It will highlight the importance of establishing specifications for all test challenges, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.
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4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs
Nanda Subbarao
Product Id: 704730
This training program will provide an introduction to regulatory expectations for data integrity, discuss generation, review and archiving of data, enumerate evolving requirements for eData, and expound on support systems for data integrity.
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Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products
Kim Huynh-Ba
Product Id: 704421
This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.
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Stability Program for Pharmaceuticals and Biologics
Nanda Subbarao
Product Id: 705455
This webinar will provide an overview of the stability studies required for pharmaceuticals and biologics. It will also provide a summary of recent developments in the industry and regulatory requirements in this field.
The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications
David Nettleton
Product Id: 704734
This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.
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Studies to Support Temperature Excursions and Shipping of Pharmaceutical Products
Kim Huynh-Ba
Product Id: 704770
Upon completion of this training program, attendees will learn key factors that would affect the shipping and distribution of drug products. One must understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping conditions in order to maintain quality of the drug product through expiry.
21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s
David Nettleton
Product Id: 704533
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
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Current Regulatory Requirements for Aseptically Produced Products
Kenneth Christie
Product Id: 704791
The manufacture of sterile products and the risk they represent to the public is always on the fore front of inspectors during regulatory audits. As a result, the manufacture of sterile products require a high degree of control of incoming materials, the manufacturing process and the control of personnel to name a few. A weakness in any of these items can jeopardize the sterility assurance of the final product. This training program will highlight and summarize the following main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.