Current Regulatory Requirements for Aseptically Produced Products

The manufacture of sterile products, whether by aseptic means or terminal sterilization, requires a thorough understanding of applicable regulations by the FDA and those by the EU if selling your products overseas. In addition, there are various guidance documents that address other issues such as closure integrity and sterility test methods that were recently revised.

Today, the regulatory requirements for sterile products are found in a “Guidance for Industry” document that was published in 2004. In addition, there are requirements found in 21 CFR 210-211 and 820. In all of these documents, the areas of importance and audit focus are:

  • Equipment, utility and facility qualifications
  • Validation of all sterilization processes
  • Control of the environment and potential sources of contamination
  • Personnel training and gowning requirements based on defined areas of cleanliness
  • Laboratory controls and
  • Process simulations designed to verify the acceptability of the manufacturing process and operator activities.

This webinar will discuss the most important issues that apply to sterile products in order to provide an overview for attendees to evaluate their own processes and procedures. It will not go into detail on the various sterilization methods that are used within the industry, nor will it detail how best to establish process simulations. Recent 483 observations will be reviewed to help highlight common industry deficiencies and as a reference to compare attendees current practices.

Areas Covered in the Session :

  • Review the current regulatory requirements and guidance documents dealing with sterile products
  • Review the expectations for aseptically produced products.
  • Discuss the six quality systems that are reviewed during regulatory inspections
  • Review common deficiencies cited with the manufacture of sterile drugs
  • Review the importance of personnel training and control of microbiological contamination
Who Should Attend:

  • Drug Manufacturers
  • Contract Manufacturing Companies
  • Sterile Product Vendors
  • Quality Assurance Departments
  • Quality Control Departments
  • Manufacturing Departments
  • Validation Departments
  • Production Departments
  • Regulatory Departments

FDB2367

Kenneth Christie

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the Validation Manager at Parke-Davis’ Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.