Good Documentation Guideline (Chapter <1029> USP)

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Category GDP, Good Documentation Practices, GMP Documents, Laboratory records, batch records, certificate of Analysis, SOP, standard Operating Procedure, analytical procedures, training documentation, USP General Chapter 1029 C of A, Good Documentation Guideline

Deadline: March 29, 2018 | Date: March 29, 2018

Venue/Country: Fremont, California, U.S.A

Updated: 2018-03-08 19:25:10 (GMT+9)

Call For Papers - CFP

This webinar will familiarize participants with USP Chapter on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Objectives of the Presentation

US Pharmacopeia General Chapter

History of the chapter as to how and why it was created

Purpose of development of this chapter

Chapter outline:

Principles of Good Documentation

Data collection & recording

Different types of GMP Documents

Laboratory records

Equipment-related documentation

Deviations and investigations

Batch records

Certificate of Analysis (C of A)*

Standard Operating Procedure (SOP)*

Protocols & reports*

Analytical procedures*

Training documentation

Retention of documents

Why Should you Attend

Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.

This training session will cover the US Pharmacopeia General Chapter and all aspects of GDP including practices for writing and correcting documentation.

This webinar will familiarize participants with USP Chapter on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Who will Benefit

GDP's are meant for use in the production and control of Active pharmaceutical ingredients (APIs), Medical devices, Excipients, Pharmaceutical products, Labs, Dietary supplements and Food ingredients. The following titles will benefit:

Regulatory

Compliance

Audit

Quality

R&D

Scientists

Documentation and Validation

Clinical Research

Lab Managers

Engineering and Manufacturing

For Registration

https://www.onlinecompliancepanel.com/webinar/Good-Documentation-Guideline-Chapter-1029-USP-502613/MARCH-2018-ES-OURGLOCAL

Note: Use Promo Code YDEZ6H and get 10% off on registration (Valid till MARCH 31st 2018)