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Parenteral Drug Association Connecting People, Science and Regulation ®

Preparing and Managing Documents and Documentation for Compliance

Apr 21 - Apr 21, 2017 |
Apr 21, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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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.

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

Standard

Member

On or before March 6, 2017
$1,169

After March 6, 2017
$1,299

Nonmember

On or before March 6, 2017
$1,403

After March 6, 2017
$1,559


Government/Health Authority/Academic

Member

$779

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by March 20, 2017, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

Class Schedule

All courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 - 1:00 p.m. Snacks will be provided during the morning break from 10:00 - 10:15 a.m. and the afternoon break from 2:30 - 2:45 p.m.

Location

The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

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.

Continuing Education for Pharmacists

ACPEPDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #328 | ACPE #0116-0000-17-003-L04-P | 0.6 CEUs
Type of Activity: Knowledge

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 6 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 6 PDHs.

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