The Glance team includes a powerful blend of consultants with industry experience including leading scientific and technical experts who help ensure that recommendations are not only scientifically and technically accurate, but also actionable.
Glance Consultants are particularly skilled in assessing and enhancing Manufacturing, quality assurance and quality controls—from the way technical issues are handled to the organizational structure of Manufacturing facilities.
· Validating/qualifying manufacturing processes; cleaning, sanitation, facilities,
critical utilities and equipment
· Validation/qualification policies, procedures, protocols, and master plans
· Technology transfer programs—including processes, analytical methods,
and changes
· Support for Analytical method validation, compendial method verification and
method transfers
· Staff training for ongoing validation programs
· Evaluate process designs and Develop or refine process control strategies
· Analyzing, developing, and/or enhancing engineering requirements,
specifications, and drawings, including HVAC, water, sterilization, and dust-
control systems
· Developing environmental and processing-room requirements
· Recommending effective flow of materials, equipment and personnel
· Assessing and enhancing facilities requirements of manufacturing
operations
· Addressing the facilities requirements of laboratory operations
· Performing factory acceptance testing of equipment (FAT)
· Conducting audits during construction and installation phases
· Qualifying facilities for intermediates and APIs
· GMP training for manufacturing and laboratory personnel
· Overview of GMPs for the 21st Century
· Risk-Based GMP Inspections
· Supporting in the preparation of Risk assessment report for nitrosamine
(NSA) impurities as per ICH M7
· FDA Pre-Approval Inspections
· Preparing for an Inspection and Interacting with the Investigator
· Integrity of Records and Data
· Evaluating written procedures and standard operating procedures
· Helping to interpret regulations in concert with industry standards
· Developing laboratory quality, analytical methods, methods validations, and
product component specifications
· Creating a program to meet current FDA expectations for GMP Compliance
· Consulting self-evaluations
· Performing trend analysis
· Providing oversight programs and enhancement—including good
governance practices; quality/compliance functions and oversight practices;
and independent advice to all members
· Implementing site oversight programs, including internal audits and
performance metrics
· Reviewing and enhancing management controls.
· Reviewing and enhancing organizational structures—including functions,
reporting relationships, responsibilities, staffing and competence;
communication systems and performance (vertical and horizontal); and
independence, staffing, and competence of quality units.
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