Development and Validation of Analytical Procedures for Small Molecules | Online intensive training | 7 part-series in 4 modules

Background: The development of appropriate analytical procedures and their validation, if applicable with subsequent transfer to routine laboratories, is one of the essential prerequisites for pharmaceutical quality control of active substances and medicinal products as well as drug-related products such as food supplements and medical devices. The intensive training covers all aspects to be considered for the analysis of small molecules. The focus is not only on the regulatory requirements (US, Europe, ANVISA, ICH, WHO), but rather on their practical implementation. A special focus is on current developments such as life cycle concepts and the new requirements for analytical validation in the US USP. Most of the aspects will be covered using HPLC as exemplarily testing procedure.

Type of Training: The training is designed as intensive training in four modules of approx. 3 hours each, 11 hours in total. The training is not only designed for less experienced participants but is also very well suited to deepen and consolidate existing knowledge for more experienced participants. The training is provided in English.

Who should participate? Personnel in R&D and QC laboratories for the testing of active substances and pharmaceutical products, medical devices and food supplements. Members RA-CMC teams implementing analytical, validation and stability testing data into the dossier. Quality assurance personnel with focus on analytical laboratory and related responsibilities.

We can offer you favourable graduated prices for group training courses. Please contact us.
You can book these events as a series or individually as part of your webinar contingent.

Module 1 (160 min)

Regulatory Requirements & Guidance Documents

• ICH | EMA | FDA | ANVISA | ASEAN | WHO | ZLG
• Ph. Eur | USP
• General Requirements Analytical Procedure Validation

Processing quality control data and data from analytical validation

• Processing of the (raw) data
• Significant figures of significant digits
• Correct presentation and documentation of the data (rounding/truncating/averaging)
• Data integrity

Module 2 (180 min)

Basic requirements and validation parameters

• Parameters to be validated
• Verification of compendial methods
• Acceptance criteria (with different regional requirements)
• Descriptive statistics
• Equivalence versus significance tests
• Single versus multiple determinations
• Setting of acceptance criteria
• OOS | OOE | OOT

Module 3 (150 min)

Analytical procedure Development and Prevalidation

• Starting points for the development of analytical procedures
• Optimization of separation | Simulation software
• Development of sufficiently robust test procedures
• Development of stability indicating test methods
• System Suitability testing
• Use of response factors

Life cycle Management of analytical procedures

• Life cycle of analytical procedures (FDA, WHO, ICH Q14)
• New USP chapter <1220> Lifecycle Management of Analytical Procedures and <220> Basic requirements for Lifecycle Management of Analytical Procedures der USP
• Control charts and trending
• Postapproval validation activities and change control
• Adjustment of analytical methods and procedures versus changes

Module 4 (180 min)

Stress test & forced degradation testing

Validation of analytical procedures in dissolution testing

Transfer of analytical procedures (co-validation), cross-validation, revalidation

• Regulatory requirements (ZLG, Ph. Eur., EU-GMP, USP, FDA, ANVISA)
• Project management
• Success factors

Regulatory documents and GMP-Documentation related to analytical validation

• Responsibilities
• GMP validation masterplan
• GMP validation protocol
• GMP validation record
• GMP validation report
• Regulatory report

Duration: between 150 - 180 minutes per module
Language: English | Handout: English

...more from your speaker Dr. Markus Veit...

Webinars allow you to conveniently attend training sessions and technical presentations from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.

You can also book individual parts of the series at a special price. To do so, select the series in ourcourse calender.

Note on contingent call-off: When booking this webinar described here, four units will be deducted per participant.

For group enquiries, please contact us directly at info@alphatopics.de.