TRAINING AND EDUCATION
 
 
PharmAlliance specializes in developing and conducting training programs, workshops, and seminars for clients, which are unique to their specific needs. These programs could cover any area of Regulatory Affairs and Compliance Management.

Training can be conducted in-house for all levels of management and operations personnel who are responsible for regulatory affairs, product development, manufacturing and in-process controls, quality assurance, and clinical testing and research.


TRAINING METHOD
  The training modules will be customized according to the training needs of the client.
    Modules are designed to impart training which is client-specific and relevant to the client’s
    operating environment, taking into account specific products, processes, technology,
    existing facilities and systems that form an integral part of the operations.
  Modules are designed for groups of 10 to 25 participants, to facilitate participation and
    interaction among the group and with the resource person(s).



TRAINING TOPICS:

REGULATIONS, REGULATORY PROCEDURES,
STRATEGIC PLANNING FOR REGULATORY AFFAIRS :
FDA (USA), TPD (Canada), European Union,
TGA (Australia), MCC (South Africa), WHO 
  Legislation and Regulations
  Regulatory Approval/Registration Procedures
  Regulatory Documentation
  Strategic Planning for Regulatory Affairs


COMPLIANCE MANAGEMENT FOR INTERNATIONAL MARKETS
  Good Manufacturing Practices (GMP)
  Good Laboratory Practices (GLP)
  Good Clinical Practices (GCP)
  Internal Audits, Contract Audits, Vendor Audits
  Standard Operating Procedures (SOPs)
  Records and Reports


MANUFACTURING AND CONTROL OPERATIONS
  Quality, Quality Control, and Quality Assurance
  Documentation for Quality Assurance
  Design and Construction of Manufacturing Facilities
  Sanitation and Hygiene in Manufacturing Facilities
  Personnel Hygiene, Changing and Gowning Procedures
  Equipment Design, Selection, and Placement
  Maintenance and Cleaning
  Calibration of Process and Analytical Equipment
  Materials Management
  Production and In-process Controls
  Packaging, Labeling, Storage and Distribution Operations
  Line Clearance Procedures
  Complaints and Recalls of APIs and Drug Products
  Rejection and Re-use of Materials
  Stability Study Programs for APIs and Drug Products


VALIDATION
  Validation Policy and Validation Master Plan
  Validation of Water Systems
  Validation of HVAC Systems
  Cleaning Validation
  Equipment and Process Validation
  Validation of Testing/Analytical Methods
  Validation Documentation
  Change Control

BIOEQUIVALENCE STUDIES FOR REGULATORY SUBMISSIONS

CLINICAL PHARMACOKINETICS AND PROTOCOL DESIGN FOR REGULATORY SUBMISSIONS

PRECLINICAL AND CLINICAL RESEARCH AND CLINICAL TRIALS MANAGEMENT
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