Training & Events

Good Documentation Practices

Important: The webinar is in Eastern Standard Time.

In a GMP environment, documentation needs to meet certain requirements to ensure product quality and product safety. If an instruction or record is poorly documented, then the manufacture or Quality Assurance/Control of a product can be negatively impacted, potentially reducing patient safety. This webinar will provide an overview of the principles and applications of Good Documentation Practice (GDP) as they apply to the pharmaceutical industry.

Who Should Attend:

This webinar is applicable to all personnel working within a GMP environment involved with GMP documentation e.g. Production, Quality, Regulatory and R&D.

 

Course Outline:

Documentation GMP Principle
Types of Documents and Records
General Requirements
The Basics:
– Recording Numbers

– Dealing with Attachments and Printouts

– Using Scanned Documents

Electronic Records and Signatures
 

Speaker: Josephine Wray BSc, MRSC

Josephine is a quality assurance professional with over 15 years of experience in the

Pharmaceutical, Biopharmaceutical and medical device industries. She has extensive expertise in GxP quality assurance processes, FDA, Health Canada, EU, PIC/S and ISO regulatory compliances, validation, laboratories, manufacturing, packaging and shipment areas. Josephine has worked in the UK, Singapore and Canada for small to large multinational companies and is currently in a Quality Management role for a contract biomanufacturing company. She has managed teams in manufacturing, QA and QC within the pharmaceutical field. Josephine is a member of the Royal Society of Chemistry, UK.

Date: June 15, 2020

Time: 1:00 pm to 3:00 pm EST

Members Pricing: $125.00

Non-Members Pricing: $210.00

 

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