Current Regulatory Requirements for Aseptically Produced Products


Instructor: Kenneth Christie
Product ID: 704791

  • Duration: 90 Min
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.
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Why Should You Attend:

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 in 2012.

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; 1.) equipment, utility and facility qualifications, 2.) validation of all sterilization processes, 3.) control of the environment and potential sources of contamination, 4.) personnel training and gowning requirements based on defined areas of cleanliness, 5.) laboratory controls and 6.) process simulations designed to verify the acceptability of the manufacturing process and operator activities.

This webinar is a general overview of the most important issues that apply to sterile products in order to provide an overview for attendees to evaluate their own processes and procedures. While it will not go into detail on the various sterilization methods that are used within the industry, it will review recent 483 observations to help highlight common industry deficiencies and serve as a reference to compare attendees’ current practices. The intent of this webinar is to provide a template of things to assure are in place and practiced to help assure sterility and to be compliant.

Areas Covered in the Webinar:

  • 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 Will Benefit:

  • Quality assurance
  • Quality control
  • Manufacturing
  • Validation
  • Production
  • Regulatory compliance

Instructor Profile:

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 Amhesrt, MA. His responsibilities specifically 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. He 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, he serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

Mr. Christie has a BS degree in biology from Shippensburg State University (PA) and an executive MBA degree from Michigan State.

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