10 Most Commonly Cited GMP Deficiencies
- Changes in FDA audit approaches
- Areas of focus during audits
- Most commonly cited drug GMP deficiencies
- Increase in FDA enforcement actions
Effective GMP Audits and Self-Inspections - Tools and Techniques
- Principles and Audit Planning
- Planning and preparation
- Audit types and techniques
- Internal vs. external audits
- The audit process
- Auditor Skills and Competencies
- What makes a good auditor
- Managing audits
- Initiating, Preparing and Conducting the Audit
- Materials management
- Documentation systems
- Pharmaceutical quality systems
Detailed Investigations: How to avoid an observation
- Who should be conducting an investigation?
- When is an investigation necessary?
- What constitutes an investigation?
- What is a root cause?
- What tools can be used to determine the root cause?
- What if a root cause could not be determined?
- Corrective Actions/Preventative Actions
Real Life Situations and Case Studies
- Case Scenarios – review of real-life scenarios that you could encounter during inspections
A successful audit is dependent on understanding what we could expect from regulators. This can be observed by looking at the focus of recent inspections within the industry. Such case studies will help companies to analyze their own practice and address similar issues in advance. This seminar is intended to help you prepare for and manage an FDA inspection in a proactive and effective manner. Regulators expect audits and self-inspections of the manufacturer to assure the quality of its own operations and those of its suppliers and contractors via repeated audits. FDA and other regulators have contributed to and endorsed ICH Q10, Pharmaceutical Quality System, which explicitly recommends audits as a key element in the review of process performance and product quality and also in the management of outsourced activities and purchased materials.
Why You Should Attend:
Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal GMP audits in order to find and correct areas where the firm is not in full compliance with the GMP regulations before an FDA audit occurs. There are several problems with this approach, however. The auditors may not fully understand the regulations and may not have been trained in audit techniques. Another impediment is that an internal auditor is monitoring his/her friends. It is very difficult to point out errors committed by a friend since by calling attention to a lack of compliance may be interpreted as “telling on” the friend and possibly causing a problem for them.
This seminar will provide you with the knowledge, understanding, skills and confidence to audit all aspects of pharmaceutical manufacture and control, whilst retaining the cooperation and respect of the other auditors.
1. 10 Most Commonly Cited GMP Deficiencies
2. Effective GMP Audits and Self-Inspections - Tools and Techniques
3. Detailed Investigations: How to avoid an observation
4. Real Life Situations and Case Studies
- Quality Assurance Departments
- Quality Control Departments
- Production Departments
- Logistics Departments
- Manufacturing Departments
- Regulatory and Compliance Departments
- Quality System Auditors
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.
To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called aseptic-process.net, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector. Recently, he is in the process of creating webinars so he can share pertinent information about pharmaceutical manufacturing from a microbiological perspective.
Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.