Process and Cleaning Validation

4.5 rating based on 24 ratings. 24 students

Process and Cleaning Validation

Training about all the ins and outs of process and cleaning validation

4.5 rating based on 24 ratings. 24 students

GMP & GDP training for pharma & biotech

Language(s):

1 day in total

 922 ex. VAT

Registration ends in 120 days.

What you'll learn

Employ Quality by design in development of new processes

Understanding the effect of good startup to avoid problems later on

Systematically set up and plan validations in accordance with legislation

Description

Training

One-day training on validation according to the current understanding: design phase, qualification phase and continuous verification. The traditional way of validation, where a protocol is simply performed 3 times, is definitely behind us. Since the beginning of this century, several guidelines have been introduced in which the development and planning phase have become increasingly important in the life cycle of a pharmaceutical product or GMP system (and nowadays GDP). The emphasis is on Quality by Design, setting up Design of Experiments, performing risk analyses and establishing an efficient control system. Organizations often experience too late that their validation approach is insufficiently robust and therefore experience problems, such as registration or inspections, but also because processes do not run as expected. A solidly planned approach to validation is necessary to comply with regulations, but also to avoid financial and quality risks. The implementation of the underlying systems is also covered, such as Data Integrity, Good Documentation Practices and Risk Management which are very important components for the proper design of validations. PCS has introduced this training, in which this vision on validation and the underlying quality enablers are extensively covered. This training is for employees in the pharmaceutical industry who are involved in designing, implementing and collaborating on validation. For validators, production staff, QC, auditors, QA, QPs and managers

Content

  • Purpose of validation
  • Laws and regulations (including Annex 15, ICH Q8, Q9, Q11, FDA)
  • Design and execution of process validation
  • Design and execution of cleaning validation
  • Quality by design
  • Risk analyses
  • Establishing an efficient control system
  • Data Integrity as an important part of validation
  • Validation Master Plan
  • Reporting
  • Workshops - learning by doing
Course content

LectureDay
Introduction to the course

1
Regulation in validation

  • Paradigm change
  • Regulation
  • Data Integrity
1
Design phase

  • Process manual
  • Record of studies performed
1
Roadmap for validated processes

  • Decide on approach
  • Create roadmap based on case
1
Start qualification phase: set up and pre-studies

1
Qualification phase: planning validations

  • How to organize validations
  • Sample plan
  • Testing
1
Workshop - how to prepare executives?

1
Continuous verification

  • Management review
  • Process Capability Index (CPK)
  • Process Control - re-qualification (when), process control and change control
1
Other validations

  • Cleaning validation
  • Analytical method validation
1
Validation in your own practice

1
Quiz (Kahoot) and conclusion

1

Course dates

Start dateEnd dateVenuePriceStatus
24-09-202424-09-2024PCS Training Room 922 ex. VATRegister

Language

  • Dutch spoken language

General information

Learning form:Classroom
Times:The course starts at 9:30 am and ends at 5:30 pm
Venue(s):
Start dateVenueRegister

24-09-2024

PCS Training Room

Register

Preparation:
Preparation required:Preparation requirements to be announced
Preparation details:N/A
Exam:
Includes exam:No
Process and Cleaning Validation thumbnail
 922 ex. VAT

Registration ends in 120 days.

This training includes:

Training certificate

Lunch buffet

11 Lectures

Training 5 people or more?

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