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 3. Self Inspection Techniques - Avoid the most common and recent FDA
    observations


SELF INSPECTION TECHNIQUES - AVOID THE MOST COMMON AND RECENT FDA OBSERVATIONS

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SEMINAR AGENDA:

Day 1 (11 AM to 2 PM)

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





Day 2 (11 AM to 2PM)



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









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SEMINAR OBJECTIVES:

 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 

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About The Course:


About Faculty: CARL PATTERSON 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.

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.


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Who 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. 





seminar Self Inspection Techniques FDA observations FDA Medical Device
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