Pre-Audit Inspection

Increased regulations have produced a necessity for compliance standards to be implemented before inspections occur. The Pre-Audit Inspection process will identify the necessary factors that need to be addressed before you face the strict standards of the FDA. A negative FDA report can result in decreased internal productivity, and a sharp drop in profits. Problems with future contracts, legal roadblocks, diminished reputation and safety hazards are just a few of the adverse factors involved in being unprepared. Leveraging regulations and compliance with Pre-Audit functions allows you to mitigate potential problems that may arise and provides your organization with a well-rounded view of steps that need to be taken to assure a seamless FDA inspection.

Within the PAI training attendees will be presented with a risk management approach to Review Board Inspections. Self- audit techniques will be offered so your organization can assure compliance before inspectors arrive. The two-day training will dive deep into the PAI process, uncovering best practices for meeting regulatory standards before they can negatively affect organizational stability.

Meet the Instructor:

Jim Ingram
Ingram Consulting Services
Jim has over 20 years of management experience in the Manufacturing and Packaging of Pharmaceutical, Food and Cosmetic Products (Including over10 years with GlaxoSmithKline). He has had direct responsibility for compliance with government agencies such as FDA, EPA, DEA and DA throughout his career. Processes and training programs developed by Jim have resulted in improved FDA audits and relief from Consent Decrees over the pass 9 years as an independent consultant. Jim received his Associates Degree in Engineering from Central Carolina Technical College and attended Campbell University Business School. He has numerous patents to his credit and is a Certified Packaging Professional with the Institute of Packaging Professionals.

Training Benefits Include:

  • Establish a regulatory compliant setting by executing best practice procedures
  • Implement proven auditing methods to successfully complete internal audits
  • Learn the most effective ways to apply Corrective and Preventative Actions (CAPA), conduct Root Cause Analysis(RCA) and properly prepare for systems-based drug cGMP and QSIT inspections

    • 10 Reasons to Attend:

  • Learn best practices over the span of a two day workshop
  • Interact with instructor and attendees to assure PAI understanding
  • Prepare yourself for inspection obstacles
  • Establish proven self- audit programs
  • Understand the expectation of FDA investigators
  • Mitigate risk by addressing regulatory standards
  • Communicate compliance standards that need to be employed
  • Interact appropriately with FDA investigators
  • Assess development and manufacturing practices that will be targeted
  • Gain tools needed to implement a PAI process in your organization

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