Cgmp Regulatory Inspections Course: See Through The Eyes Of FDA, EMA And PMDA (ONLINE EVENT: November 13, 2024/ON-DEMAND)
Cgmp Regulatory Inspections Course: See Through The Eyes Of FDA, EMA And PMDA (ONLINE EVENT: November 13, 2024/ON-DEMAND) . (MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA" training has been added to ...
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(MENAFN- GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA" training has been added to ResearchAndMarkets.com's offering.

cGMP or current good practices are not limited to product development and monitoring of the SOPs. Everything plays an essential role, starting from the design of the facility, the strength of the unit, and the purity of the components.

Do you have the proficiency to update cGMP to its core? You will, after attending this cGMP training! The core purpose of this seminar is to establish a robust idea of how the quality of active pharmaceutical ingredients.

Course Overview

Do you think a consumer will be able to assess the quality of the drug? This is difficult by just smelling, touching, or looking at the final product. Hence, you need thorough pharmaceutical GMP training to ensure every consumer receives high-quality drugs.

Since a basic cGMP course is not sufficient to ensure quality, the effort is to improve the overall conditions under which a pharmaceutical product is manufactured. As a result, you will see a dip in cGMP violations, and the operations will improve significantly.

As per FDA GMP inspection guidelines, here are some controls they focus on:



Improving management systems

Reliable testing of the samples, raw materials, and final products

Developing strict operating procedures

Consistent work on reducing the deviations

Procuring quality raw materials Thorough investigations of the deviations

By adhering to this FDA GMP inspection checklist, you can avoid the most common quality failures in your manufacturing unit. The 58-page document on cGMP has excellent updates which will be discussed in this cGMP training.

Who Should Attend:



Manufacturing

Quality Control

Quality Assurance

Senior Management

Project Managers

Qualified Persons (QPs)

Regulatory Compliance

CMC Personnel

Packaging Experts

Auditors and Staff IT Subject Matter Experts

Key Topics Covered:

Session 1:

U.S., EU, and Japan GMPs - Status of Harmonization& Future Trends



Current status of harmonization of GMP requirements Future Trends

Where Inconsistencies Become a Problem: WHO, ICH, Countries



Discrepancies in global expectations Alignment issues

Key Chapter Reviews



ICH GMP organization Category reviews

Compliance with ICH Guidelines for GMPs



Understanding and Insight into Healthcare Authority expectations

How GMP requirements/inspections can differ with a single ICH Standard How regulators (from 3 regions) will assess/enforce compliance with Q7

Session 2:

APIs



Auditing API facilities

Typical audit agenda ICH Area differences

Finished Products



Auditing finished product facilities

Typical audit agenda ICH Area differences

Excipients

Sterile products

Biologics

Clinical Packaging

Session 3:

Area GMP Inspections



Differences on how GMP inspections are conducted

Areas of GMP inspection focus by area Modifying your self-inspection systems to customized area concerns

Outsourcing Management Regional Perspective on:



Contract manufacturing

Contract packaging. 3rd Party Contract testing

Auditing Your Facilities for Global Considerations



Importance of pre-audits to regional GMP focus. How to focus your internal audits to a US, EU and Japan compliance system.

Speakers:

Kelly Thomas

Vice President

Stallergenes Greer

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

For more information about this training visit

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2024-11-08
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(MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA" training has been added to ...
Cgmp Regulatory Inspections Course: See Through The Eyes Of FDA, EMA And PMDA (ONLINE EVENT: November 13, 2024/ON-DEMAND)