Deviation Management – Why have we not solved the problem? Live Webinar

MP3 Download / On Demand Webinar Duration 60 Minutes

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Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Training Overview

Deviations occur across the pharmaceutical and device industries nearly every day. Hundreds of hours and thousands of dollars are spent to address deviations. Yet with all of the investment to investigate deviations, identify their causes and implement corrective actions, both personnel and management are frustrated as the same problems recur. For nearly 25 years, FDA and other regulators have annually cited failure in problem investigation systems within the top 5 of all observations issued.

 So, what are we doing wrong? This seminar will discuss the reasons for deviation failures and provide solutions for success. 

Why Should You Attend

One of the top 5 issues annually identified by FDA and other regulatory agencies during inspections is deviations. In this webinar, we explore why are we continuing to be cited, fail to solve our problems and create documentation that fails to satisfy auditors and inspectors. We will discuss what we can do differently to change this cycle and more importantly, bring true resolution to problems. 

Webinar Takeaway

  • A common understanding of words and definitions and why this understanding matters
  • 5 unrecognized failures in our foundational knowledge that is at the core of what we do, think and write
  • The job that is done
  • The documentation that is created
  • The responsibilities that are assigned
  • The knowledge of the systems we investigate
  • The tools to use and when to use them
  • The consequences / impacts of each failure on operations and compliance profile
  • What can be done differently?
  • New ways of thinking
  • New ways of writing
  • New ways of behaving
  • New prioritization on the timing of investigation

Key Learning Objectives

  • Sources of failure in deviation systems
  • Root causes for these deviation system failures
  • How timing impacts the investigation success
  • Tools to avoid failure and how to achieve success
  • How to take credit for doing good work
  • How to convince Yourself and others that you got to the root cause

Who will Benefit

  • Quality Assurance Personnel and Management
  • Operations personnel and Management.
  • Investigators
  • Deviation investigators
  • Reviewers and approvers of deviation investigations
  • QA staff and management
  • Regulatory affairs staff and management
  • QC staff and management
  • Compliance auditors
FDA Faculty David W. Husman

David W. Husman, Ph.D., ASQ CPGP, RAC

Experienced Consultant in Pharmaceutical and Medical Device Industries |Trainer | Based in Greenville |Open to Traveling

Taylors, South Carolina

Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 20 years as a consultant to biopharma, pharma and device industries.

Experience has spanned from R&D to Commercial Manufacture

Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.

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Our Participants Testimonial

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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