Pharmaceutical Good Manufacturing Practice

Why Attend

A robust quality system that meets the requirements of pharmaceutical regulators is an essential element of every good pharmaceutical manufacturing operation. This course will introduce participants to the essential features of a US Good Manufacturing Practice (GMP)-compliant quality management system as well as covering recent developments in pharmaceutical regulation. The duties of personnel in the production, quality control and quality assurance departments will be explained, together with requirements for GMP-compliant documentation and records. The expectations of regulators regarding the qualifications, experience and on-going training/development of personnel will also be covered.

Special emphasis will be given to the relatively recent topic of pharmaceutical data integrity, including controls required over quality-critical electronic data systems. Participants will also be introduced to the concept and application of quality risk management in a GMP environment.

Course Objectives

By the end of the course, participants will be able to:

  • Explain the importance of Good Manufacturing Practices (GMP) in ensuring patient safety and drug efficacy
  • Apply US-compliant pharmaceutical standards to enhance the current pharmaceutical quality management system within their own organization
  • Find and continuously implement the current GMP requirements and updates frequently released by US authorities
  • Implement pharmaceutical data integrity regulations
  • Produce GMP-compliant documents, records and written procedures
  • Prepare for regulatory inspections as well as internal and supplier audits

Target Competencies

  • Good Manufacturing Practice
  • Understanding Pharmaceutical Quality Systems
  • Performing Pharmaceutical Audits
  • Data Integrity
  • Producing GMP documents

What is the target audience?

Target Audience

This course is designed for production and quality control professionals in the pharmaceutical manufacturing industry. It will be particularly beneficial for individuals responsible for compliance or quality assurance such as quality auditors, regulatory affairs professionals, production auditors, regulators, training and production managers, as well as anyone interested in effective GMP compliance tools and techniques. Professionals working with finished pharmaceuticals, combination products or devices will also gain insight on how to better structure their respective quality systems.

Statistics for doctors - what they want to know

1
Overview of a scientific article
2
The question and the evidence based answer
3
Different study designs in practice
4
Dissecting a trial
5
Presenting the data
6
Statistics for the doctor

Communicating with doctors

1
Basics of communication
2
Different communication styles
3
Discovering the doctor’s communication style
4
Breaking the “one-size-fits-all” approach
5
Differentiating between the promotional message and the medical message

Different physician profiles and challenges

1
The art of observation
2
Getting the message across
3
Making a big impact in little time
4
Building a foundation
5
Addressing concerns
6
Answering different questions and their purpose
7
What to say and when to say it

Factors influencing the treatment choice

1
Different physician perspectives
2
Different physician profiles
3
Addressing the concerns
4
Presenting the data
5
Challenging questions and suggestions
6
Facilitating access

Marketing and promotional events

1
Different types of events and their intended purposes
2
Choosing the target audience
3
Working with speakers and attendees
4
Assuring the scientific benefit
5
Relaying the message while preserving ethical and high educational standards
26 - 30 April 2021

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Lectures: 29

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Working hours

Monday 9:30 am - 6.00 pm
Tuesday 9:30 am - 6.00 pm
Wednesday 9:30 am - 6.00 pm
Thursday 9:30 am - 6.00 pm
Friday 9:30 am - 5.00 pm
Saturday Closed
Sunday Closed