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  February 25, 2020  
CfPA- The Center for Professional Advancement, Edison, NJ
June 25-26. 2020

Who Should Attend?
This introductory/intermediate course is designed for individuals who need a basic, but thorough understanding of the Installation/Operational/Performance Qualification Process for equipment and systems in support of Process Validation for the manufacture of regulated products. The course will benefit individuals in:
  • Engineering
  • R&D
  • Technical Services/Validation
  • Regulatory Affairs
  • Production
  • University and allied health care professionals
  • Quality Control/Assurance

Managers and supervisors of the above listed individuals would also benefit from this training by becoming acquainted with, and better understanding, the challenges and timelines for proper qualification.

Course Description
The Installation/Operational/Performance Qualification of equipment, systems and facilities for sterile, oral solid dosage forms, liquids, finished and bulk drugs in the Pharmaceutical and Bio Pharmaceutical manufacturing operations are essential parts of the overall validation process. Equipment and systems must be installed, operated and maintained within design specifications and facilities must be accepted as fit for use. Lastly, processes must be shown to be reliable and robust to assure the consistent quality and integrity of the final product.

This course provides a basic and thorough understanding of preparing, executing, reviewing and approving qualification protocols. A Risk Based approach to impact critically assessment is also provided along with an overview of ICH Q9 Quality Risk Management and ASTM E 2500 approaches now being applied by the industry.

Though no library of completed protocols will be provided, examples and workshops will be utilized to enhance learning.
Organized by: CfPA- The Center for Professional Advancement
Invited Speakers:
   Charlie Neal, Owner and Senior Consultant for Premier Quality Consulting

Charlie Neal, Jr., Owner and Senior Consultant for Premier Quality Consulting, has been in the Pharmaceutical industry for over thirty-five years. He has a wealth of hands-on technical experience acquired from the chemical, drug, device, and pharmaceutical industries. His experience crosses into many areas of these industries including Research, Development, Process Engineering, Validation, Technical Transfers, Manufacturing, Quality, Compliance, Project Management and Sales and Marketing.

Mr. Neal has written and presented numerous papers on Qualification and Validation and their requirements in the Life Science industry. His expertise was further expanded while an active member of the Institute of Validation Technology’s Editorial Board. Mr. Neal has written and published articles on Technology Transfers and has presented on these topics internationally, including in Tokyo, Japan. He has authored a chapter on Transdermal Process Validation that was published in the 3rd edition of “Pharmaceutical Process Validation”.

His company, Premier Quality Consulting was established to offer consulting expertise to the Pharmaceutical and Bio-Tech companies.
Deadline for Abstracts: N/A
Registration: Please click here for registration information.
E-mail: knee@cfpa.com
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