Good Documentation Practices – What Helps Make Your Controlled Documents Compliant

Officially there is no requirements as per the FDA and other regulatory bodies for “good documentation practices”, however, it is a “current” industry practice and if often reviewed and cited by auditors during audits. All legal and controlled documents are subject to the retention of information which should include the sign and dating of such data by the person responsible. Good documentation practices are expected to assure that all recorded data is accurate, legible and traceable. We all know that the FDA strongly believes “if it wasn’t documented, it didn’t happen”. FDA also wants to see how you document results. It’s also been observed that the lack of good GDP is consistently cited in FDA 483 observations. The training departments need to make GDP an integral part of every employee training.

Why You Should Attend:

A basic overview of good documentation practices will be covered in this webinar. It will also include examples of practices that not acceptable to auditors. A sure-fire way for auditors to find gaps in the quality unit processes is poor documentation practices. You must ensure documentation errors found must be corrected so that you are fulfilling the responsibilities for review of documents. This webinar will ensure attendees can review their own procedures confidently. It will also address what should be included in applicable training sessions for employees. The topics that are covered are important for activities ranging from the review of qualification protocols to the recording of information found in batch records and beyond.

Areas Covered in the Session :

  • What is the definition of good documentation practices?
  • Review of examples of good documentation practices and what they apply to
  • Examples of documentation practices that should be avoided
  • Review of practices for correcting mistakes or when space is limited for comments
  • Review of FDA 483 citations give to companies

Who Should Attend:

  • Regulatory Affairs Departments
  • Quality Departments
  • Compliance Departments
  • Research and Development Departments
  • Engineering Departments
  • Manufacturing Departments
  • Validation Departments
  • Management Teams

FDB1969

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
.