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COURSE ID 1789

Packaging Process Validations: Pharmaceutical and Medical Devices

AVAILABLE On-demand
12 Hours

On-Demand

Offering Price
$ 2330
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Team Training

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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

ACCREDITATION CEU's - 1.2 IACET
View Course Outline

The integrity of a package depends on the qualification of the packaging equipment, the packaging process, and consistent performance throughout the commercial packaging run. No matter how well the container/closure has been developed, it cannot protect the product as designed if it is not properly sealed and packed. The packaging process validation ensures that packages are sealed and packed correctly.

This intensive, 12-Hour course provides an in-depth overview for packaging validation practices. The training will help ensure the product packaging conforms to its predetermined specification. Targets include consistent quality to the consumer, compliance with regulatory requirements, safety, cost effectiveness, financial and other company benefits.

Controlled processing from translated user requirements to measurable packaging specifications is discussed. There is emphasis is on practical ways to implement packaging validation, using protocols, SOPs, planning, statistics, process controls and other tools. The Validation-Master Plan/ Protocol, protocols, templates for IQ, OQ and PQ are described.

who should
attend?

LEVEL
Intermediate
INTERESTS
Biotechnology / Biopharmaceutical Cosmetics / Personal Care & Skin Care Medical Devices / Diagnostics Pharmaceutical Science & Technology

This training is especially designed for personnel involved with packaging process validations for pharmaceutical and medical devices packaging. Active participation and questions are encouraged throughout the course presentation. Professionals in the following departments will benefit greatly from this training:
– Package Engineering
– Supplier Development
– Manufacturing
– Product Development
– Supply Chain/Logistics
– Quality/Quality Assurance

course instructor

Jan Gates
President/Principal Packaging Engineer, PackWise Consulting | MSU, Bachelor of Science in Food Science and Master of Science in Packaging

Jan Gates’s Courses
Jan Gates has 30+ years of experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed to meet regulatory, product protection, and customer use requirements; also, included are production optimization, validation, and minimal packaging for sustainability. She has previously worked for Bristol Myers Squibb, Conagra, Lever Brothers, Dade Behring, and Abbott Vascular. She currently works as a consultant in her company PackWise Consulting and with Adept Packaging. Ms. Gates works with ASTM D10 and F02 committees for rigid/flexible packaging and environmental package testing. She is also working as a US representative on various ISO TC 122 committees for packaging tests, vocabulary, labeling, and temperature-controlled product shipment. She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices). The AMMI TIR 22 document has been converted into ISO/TS 16775.

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