GMP training, Vendor GMP & Regulatory inspections in Pharma, Biologics

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Location

Hyatt Regency Princeton

102 Carnegie Center

Princeton, NJ 08540

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Event description

Description

This 2 Day Expert led Interactive Seminar gives you all the details needed to deal with GMP requirements, intricacies of how to select, qualify & monitor CMOs/CROs/Contract Labs and deal with regulatory inspections. Discuss amongst a small group of like minded professionals. Apply the learnings to your everyday job right away!

Learning Objectives

To understand all the GMP requirements
Understanding the intricacies of how to select, qualify and monitor CMOs, CROs and Contract Laboratories
Learn the elements to include in a quality agreement (also known as a technical agreement)
Learning the importance of maintaining data integrity

Learn how to effectively manage a regulatory inspection: Inspection logistics

Responding effectively to document requests & questions from inspectors
Managing the inspection exit discussion
How to write an effective response to inspection observations
How to find applicable inspection references and procedures of the FDA, EMA and Health Canada

This Huddle Seminar will provide participants with an understanding of common terminology and the role GMP plays in their day-to-day responsibilities. Focus is given to the regulatory nature of CGMP compliance, managing the implementation of GMP efforts and proactively sustaining a culture of compliance in all scientific and manufacturing efforts.

Who Should attend?

This GMP Huddle is designed for those who work in a cGMP environment, both beginners and advanced professionals. It is designed for all those who have roles and responsibilities that require them to understand and apply cGMP quality principles in their job as related to product discovery, development, and/or manufacturing.

  • Directors
  • Managers
  • Supervisors
  • Auditors
  • Regulatory operations
  • Quality Assurance
  • Project Management
  • Vendor Managers
  • Contract Management
  • Compliance Officers
  • Anyone needs to work in a cGMP environment

Session Expert: Ms. Joy L McElroy, President/CEO, Maynard Consulting, (former Abbott, Wyeth)

Upon earning a degree in Zoology at North Carolina State University, Joy entered the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

FAQs

What are my transportation/parking options for getting to and from the event?

Hyatt Regency is well located near US 1, within driving distance from all major pharma companies. Parking is Free onsite.

How can I contact the organizer with any questions?

Please write to us at brian@plianced.com or support@plianced.com

What's the refund policy?

Full refund is issued untill 5th July 2019

Do I have to bring my printed ticket to the event?

No

Can I update my registration information?

Yes you can write to us at brian@plianced.com

Is my registration fee or ticket transferrable?

Yes

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Date and Time

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Hyatt Regency Princeton

102 Carnegie Center

Princeton, NJ 08540

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