Preparing and Managing Documents and Documentation for Compliance - New Course

Bethesda, MD
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

How many times have you heard: if it isn’t written down, it didn’t happen? Documents and documentation are the foundation of the pharmaceutical arena. Procedures must reflect practices and practices must reflect procedures. Proper preparation, completion and management of clear and concise documents result in productive and compliant operations, fewer deviations, and a positive impact on the bottom line. During this course, the instructor will examine FDA and EU regulatory requirements and expectations for GMP/GDP documents, how to prepare those documents, and the completion and management of documentation, as well as the consequences of non-compliance.

Documents such as Standard Operating Procedures (SOPs), Work Instructions (WIs), forms and batch records are a fundamental part of a successful quality system. These documents establish, secure, control and monitor tasks, and serve as evidence of compliance. Poorly written documents are of limited value; the best-written documents are worthless if they are not followed. To that end, companies must prepare and write effective procedures with consistency, clarity and credibility.

Documentation is an everyday activity. Whether to demonstrate production activities, describe investigations or finalize product release, the recording of sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, employees must follow good documentation practices and properly manage documents.

In this course, identify why some documents are difficult to use and not readily accepted by the users and then reveal methods for the preparation, development and storage of documents. Also, learn to examine and diffuse the difficulties in using and managing documents by understanding key aspects of good documentation practices and those illusive and erroneous documentation management systems and activities that linger in our facilities.

Who Should Attend

This course is for individuals who are responsible for creating and/or authoring documents and ensuring readiness for the application and use in a GMP/GDP (Good Distribution Practices) environment. Individuals who conduct internal GMP/GDP audits will also benefit from this course.

More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Explain the importance of document nomenclature and hierarchy
  • Recognize personnel and system responsibilities and expectations
  • Identify the phases of document lifecycle
  • Employ elements of efficient and effective document writing
  • Explain the importance of document training
  • Determine training strategies
  • Recognize key aspects to electronic signatures and records
  • Describe copying, printing, storing, retention, retrieval and destruction practices
  • Formulate a unique approach to good documentation practices
Agenda is subject to change.

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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD , United States

Kerry P. Potter, Founder and Principal Consultant, Summit Consulting, Inc.

Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA Quality Management System manager, 5S coordinator, cGMP and GMP trainer, OSHA regulations and Process Safety Management training, as well as internal and external public relations.

As the founder of Summit Consulting, Inc., Kerry has supported pharmaceutical firms (domestic and non-domestic) in the areas of systems remediation and project management within their quality, manufacturing and the laboratory functions for the past ten years. Summit Consulting offers a combination of business and hands-on experience along with its consultation, training and mentoring services for the pharmaceutical manufacturing industry. The mission of Summit Consulting is to help clients fulfill their immediate needs and tasks, determine their peak potentials, and attain the highest level in their success.

Kerry is a graduate of James Madison University in Harrisonburg, VA (B.S., Chemistry) and is an advanced Toastmaster. He has received qualifications and certifications in the areas of auditing, facilitation and training. His past affiliations have included ASQ, ASTD, PDA, GMP-TEA, ASPI, and AQP. Kerry and his wife, Karen, reside in the Shenandoah Valley of Virginia.