Fundamentals of Good Manufacturing Practice: Drug Industry

Course Code: BETCO/001

Description: GMP is a set of guidelines that ensures product safety, quality and efficiency which all pharmaceutical manufacturers are required to comply. Nothing contributes more to your firm profit or loss than your personnel. The ideal situation is to have the right employee in the right position at the right time doing the right process. To achieve this consistently in your organization, you must have effective and efficient GMP training program. The factors covering GMP are numerous and all personnel are required to have some basic understanding of each components affecting GMP.

Learning Outcomes: This course will give participants a basic understanding of GMP. Participants will know in brief all the requirements for quality products, concept of GMP, different basic components to GMP. A brief overview of the documentation system as required by GMP is also covered. This course will show the participants what is needed to implement and comply with GMP to avoid surprises in government audits. This training will help organization in reducing the risk of failing an audit or self-inspection.

Target Audience: This course is made for nonprofessional junior staff who are working in pharmaceutical and biotechnology industry. For example,

  • Manufacturing machine operators

  • Quality control laboratory technicians

  • Service staff

  • Engineering technicians

  • Store staff

  • Manufacturer packagers of all levels

  • New recruits

  • Solution preparation unit personnel

  • Inspect

    123

    345

    6778

    ion line staff

  • Quality assurance inspectors

  • Line supervisor and operators

Methodology: PowerPoint Presentation and Case Studies Exercises

Training Agenda:

QA, GMP, and QC

0.5 hours

Lesson 1

Contamination

0.5 hours

Lesson 3

Protective Clothing

0.5 hours

Lesson 5

Warehouse

0.5 hours

Lesson 7

Cleanrooms

0.5 hours

Lesson 9

Case Studies - Part 1

1 hour

Lesson 11

Documentation

0.5 hours

Lesson 2

Mix up / damage / check

0.5 hours

Lesson 4

Cleaning

0.5 hours

Lesson 6

Laboratory

0.5 hours

Lesson 8

GMP inspection process

0.5 hours

Lesson 10

Case Studies - Part 2

1 hour

Lesson 12

Fax: +1.208.692.3071

Email: betcocenter@gmail.com​

Webwww.betcocenter.com

P.O. BOX 124993,

Sharjah, United Arab Emirates.

SAIF - Zone, Office # P8-04-30