Highlights of the Latest Critical WHO Guidances: A Need-to-Know for Global Product Development

Good Manufacturing Practices for Active Pharmaceutical Ingredients
Good Practices for Pharmaceutical Quality Control (QC) Laboratories
Good Data and Record Management Practices

Live, Interactive Training Webinar

Date: Wednesday September 26, 2018
Time: 9:30am - 11:30am ET (New York Time)
Instructor: Kim Huynh-Ba Biography>>>


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World Health Organization (WHO) is an agency of the United Nations that is concerned with international public health. Their goal is to direct and coordinate international health within the United Nations’ system; therefore, the quality of pharmaceutical product is a continuing concern of WHO. To respond to the global need for adequate quality assurance of pharmaceutical products, the WHO has published several guidelines and made numerous recommendations to countries to establish their standards. This interactive webinar will cover the highlights of 3 most important areas that WHO has established guidelines.

In 2010, the WHO issued a guidance on GMP for Active Pharmaceutical Ingredients (API) manufactured by chemical synthesis to ensure that APIs meet the requirements for quality and purity. This guidance covers all operations of receipts of materials, production, packaging/repackaging, labelling/relabeling, quality control, release, storage and distribution of API. Several important factors applied to the manufacture of APIs for use in finished pharmaceutical products.

The Quality Control (QC) laboratory plays a critical role in the entire development process. A guidance was developed to cover critical functions and robust quality systems necessary to ensure that the product meeting established specifications and procedures satisfy regulatory requirements including documentation and laboratory inspection.

Data integrity is a critical concern in the pharmaceutical industry. To date, the number of observations regarding good data management has increased significantly during Good Manufacturing Practices (GMPs) inspections. In October 2015, the WHO has issued a draft for Good Data and Record Management Practices to ensure that the data and information submitted in dossiers and used in day-to-day decision making process is reliable, accurate and compliance.

Learning Benefits:

Good Manufacturing Practices for Active Pharmaceutical Ingredients (API)

• Principles of quality management system in API manufacturing
• Materials management and In-process controls
• Requirements of validation

Good Practices for Pharmaceutical Quality Control (QC) Laboratories

• Understanding the importance of the QC laboratories
• Ensure that policies and procedures are adequate to assure the quality of test results that it generates.
• Establish documentation system to ensure accuracy and compliance with current standards.

Good Data and Record Management Practices

• Understand ALCOA principles for good data management
• Principles of Good Documentation Practices
• Design systems to assure data quality and reliability

Webinar outline and time breakdown:

Time*
09:15 AM Log In Period
9:30 AM Introduction
9:40 AM Good Manufacturing Practices for Active Pharmaceutical Ingredients (API)
• Principles of quality management system in API manufacturing
• Materials management and In-process controls
• Requirements of validation
Good Practices for Pharmaceutical Quality Control (QC) Laboratories
• Understanding the importance of the QC laboratories
• Ensure that policies and procedures are adequate to assure the quality of test results that it generates
• Establish documentation system to ensure accuracy and compliance with current standards
10:30 AM Break
10:40 AM Good Data and Record Management Practices
• Understand ALCOA principles for good data management
• Principles of Good Documentation Practices
• Design systems to assure data quality and reliability
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • An electronic copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Analysts and Laboratory Managers
  • Regulatory Affairs Professionals
  • Pharmaceutical Scientists
  • Compliance Scientists
  • Manufacturers of raw material and ingredients

Registration Form ►


Instructor: Kim Huynh-Ba

Kim has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she held technical positions in drug development at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Her experiences range from analytical development to supporting CMC activities of multiple regulatory submissions, addressing regulatory responses to observations or investigations, or developing stability submission strategies.

She is an Adjunct Professor at Temple University-School of Pharmacy, Illinois Institute of Technology and Widener University. Kim currently is a member of United States Pharmacopeia (USP) General Chapter Expert Committee (2010-2015) and USP’s Reference Standard Project Team (2009-2010). She is also a member of the CHPA’s Impurities Breakout Group. She is chair of AAPS APQ Distance Learning and organized several APQ Open Forums. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS). She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” published in 11/2008, and also “Pharmaceutical Stability Testing to Support Global Markets” published in 01/2010… Full Bio>>>

 

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland