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Preparing and Managing Documents and Documentation for Compliance - New Course

May 04, 2018
Bethesda, MD

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.

  • Education

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

Overview

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.

Agenda

  • 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

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA Training and Research Institute

4350 East West Highway
Bethesda, MD

How to Get Here

By Air

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By Car

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Other Options

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Directions

Registration Fees

Regular Price

Standard

Member

On or before March 19, 2018
$1,192

After March 19, 2018
$1,325

Nonmember

On or before March 19, 2018
$1,431

After March 19, 2018
$1,590


Government/Health Authority/Academic

Member

$795

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by April 2, 2018, 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 [email protected] or +1 (301) 656-5900.

General Course Information

Please arrive at the 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.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
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: [email protected]

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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