Lecture series on Good Clinical Laboratory Practice (GCLP)

Good Clinical Laboratory Practice (GCLP) is a set of standards that provide guidance on implementing Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) principles to the analysis of samples from a clinical trial. By combining the GLP and GCP sets of guidelines, GCLP ensures the reliability, quality, consistency, and integrity of the clinical trial data generated by laboratories. Compliance with this standard assures that the data generated and results reported are credible and accurate and that the rights, safety, well-being, and confidentiality of trial participants are protected.

The programme comprises four weekly modules. It is compulsory to attend all four modules to qualify for the exit assessment. There is no relaxation to this. Each module will cover a part of the GCLP and its related exercises (individual and group).

The programme will encompass various ways to keep the learner engaged through interesting and challenging activity-based immersive learning. This programme will provide ample opportunities to seek explanations from national and international GCLP experts/trainers.

Programme agenda (module wise) will be shared with all the registered participants before the program.

During this programme, participants shall learn about:

1. Various GCLP guidelines.
2. What are GLP, GCLP, GCP and their scope?
3. Principles and practice of GCLP.
4. All aspects of clinical trial laboratory operations as per the GCLP standards.
5. How to implement GCLP in your laboratory?
6. Various challenges and how to handle them?

At the end of this programme, the participants should be able to:

1. Describe the differences between GLP, GCLP, GCP.
2. Explain briefly the requirements of each GCLP principle.
3. Identify the steps to be followed to seek GCLP compliance.
4. Illustrate how they can handle GCLP non-compliances/challenges.

• Interested personnel from the government bodies, industry, research/academic institutions, hospitals, clinical laboratories, academic, etc. with minimum academic qualification of (DMLT/BSc (MLT)/BSc/MSc/PhD/BPharm/MPharm/BAMS/BHMS/ BDS/MDS/MBBS/MD/DM) and at least 2 years of demonstrated work experience in GCLP/GCLP allied activities are eligible to apply for the programme.
• There is no age limit to apply for the programme.
• Interested personnel working in diagnostic/clinical laboratories, engaged in clinical research and engaged in research and development activities in similar areas will also be well-suited to apply for the programme.
• Limited seats are available for non-working professionals who have completed their post-graduate/doctorate degree in areas of science and technology/medical science and seeking employment.
• Only those applicants with relevant background and expertise in the area of training are encouraged to apply for the programme.
• One has to ensure and give an undertaking that she/he will attend all the four modules if selected.

To apply, please click on the ‘Apply Now’ button.
The application form comprises questions related to participant profile, academic qualifications, work experience, achievements, etc. As part of the application, the following are required to be submitted along with the application –

1. Photo identity proof with address (Driver’s License, Aadhar card, Passport)
2. Endorsement Letter from head of department/organization (For working professionals)
3. Certificate of highest academic qualification

In case of inability to upload document along with the application form, please check the size of the document. The permissible limit of each document is 1 MB.

No fee is payable.

Suitable candidates shall be selected based on eligibility criteria and the merit of their application by the Selection Committee. Applications found to be incomplete, ineligible, and redundant shall not be shortlisted for training. Candidates shall be informed of their selection or non-selection by email. Selected participants shall confirm their participation to BCIL immediately on receipt of the email by BCIL. In case the selected candidate shall be unavailable to attend the programme after confirmation, he/she shall inform BCIL immediately. Selected candidates cannot nominate another colleague/friend from their organization.

Participants must attend all four modules, as mentioned earlier. There is no relaxation and attendance shall be compulsory.

All participants who have completed all four modules will get an exit assessment link. The exit assessment has an inbuilt AI-enabled remote proctored system linked with auto-certificate generation. The participants will be handheld to complete this process.

Email may be sent to: nbmworkshop@biotech.co.in for any further queries regarding the programme.