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Validation of Purified Water Systems
Igor Gorsky
150 Min
Product Id: 704272
This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).
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Lyophilization Technology
Jerry Dalfors
80 Min
Product Id: 704028
This training program will discuss each of the critical aspects of freeze drying and the related effects of variables. The course will also discuss sublimation rate variability, heat transfer, loss of protein activity, and freezing effects on primary drying.
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Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements
Gretchen Bowker
60 Min
Product Id: 702741
This dietary supplements quality compliance training will review the FDA regulatory requirements for manufacturing and commercialization of dietary supplements. You will gain a complete understanding of FDA requirements for manufacturing of nutraceuticals, food drugs, and dietary supplements.
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Maintaining a Validated State – PV, PM and Statistics Associated with Current Regulation
Jerry Dalfors
80 Min
Product Id: 703637
This course will instruct attendees on establishing an approach to process control within each unit of operation to generate overall process control needed for validation. The webinar instructor, an FDA expert, will enumerate the importance of variation in enhancing a validated means of operation and the parameters that can cause variability. The Randomized Block statistical model will also be analyzed for effective validation.
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Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting
Roger Toothaker
60 Min
Product Id: 703214
This training on FDA compliance will provide the attendees with an understanding of FDA expectations regarding end-of-phase 2A meeting guidance. Attendees will learn the best practices to comply with the intent of the guidance and to achieve a higher quality outcome from the meeting.
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Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries
Shahbaz Shahbazi,Ray Bandziulis
75 Min
Product Id: 702614
This webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.
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Challenges of an Effective Change Control Program
Kenneth Christie
Product Id: 704638
This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.
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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.