Root Cause Analysis (RCA) For Corrective And Preventative Action (CAPA)

Root Cause Analysis (RCA) For Corrective And Preventative Action (CAPA) – The primary objective of this course is to develop an understanding of the principles and techniques involved in the practice of RCA (Root Cause Analysis).  Emphasis is placed on the practical aspects of how to perform an analysis.  In addition, this course will provide effective methods which can be used with a Corrective Action system to helps you and your team to ensure costly issues are resolved quickly and do not get dropped through the cracks. The course will provide the attendees with a system to categorize all types of issues, assign responsibility and track team activities to resolve important issues. Attendees will also learn advanced skills in root cause analysis, problem prevention, and continuous improvement.  Included will be the identification of the characteristics and changes that have contributed to simple and complex problems, and how to fix them, as well as, working with the tools and templates to capture all needed data to comply with CAPA  (Corrective and Preventative Action) reports.

 

MATERI:

1. Efficient root cause analysis programs
2. Developing effective training programs to ensure compliance
3. Respond effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions
4. Developing and implementing programs to prevent reoccurrence
5. Essential SOPs and Other Documentation
6. Understand and interpret OOS results
7. Increase accuracy through efficient documentation practices
8. Areas of FDA concerns
9. Identify and track deviations and non-conformances
10. Respond to complaints and deviations with corrective and preventative actions
11. Analyze and trend data to identify existing and potential causes of non-conformance
12. Integrate RCA with other systems: internal auditing, CAPA and complaint handling
13. Gather, organize and manage the data required to conduct RCA
14. Determine whether or not a complaint should go through a CAPA program
15. Determine internal and external reporting requirements
16. Write effective SOPs
17. Verify and validate a CAPA program
18. Perform trend analysis and use effective RCA tools (Flow Charting, Fault Tree Analysis, Fishbone Diagrams, etc.)
19. Optimize CAPA and RCA documentation procedures
20. Analyze FDA Warning Letters and common citations to avoid non-compliance

 

INSTRUKTUR:

Ratna Hindria D P S, SE, MSi, Ak, CA and Tim

 

METODE:

Kegiatan pelatihan dirancang agar peserta dapat memahami secara komprehensif materi yang disampaikan, sehingga dapat dimplementasikan secara aplikatif dalam dunia kerja. Adapun metode yang digunakan adalah:

1. Presentation
2. Discuss
3. Case Study
4. Evaluation

 

PESERTA:

This course is intended for all personnel concerned with quality and the analysis & correction of problems.  The material will be presented in such a way as to be of value to varying levels of expertise among the participants, and will be pragmatic in emphasis.  It will be particularly valuable to those newer to this field or those who wish to refresh their knowledge of these technologies.

 

FASILITAS:

1. Training Hand Out
2. Digital Material
3. Certificate
4. Exclusive Souvenir
5. Qualified Bag
6. Training Photo
7. Training room with full AC facilities and multimedia
8. Once lunch and twice coffee break every day of training
9. Qualified Instructor

 

Jadwal Pelatihan 2025

JAN - FEB	MAR - APR	MEI - JUN	JUL - AGST	SEP - OKT	NOV - DES
3 - 5 Jan	4 - 6 Mar	6 - 8 Mei	1 - 3 Jul	2 - 4 Sept	4 - 6 Nov
8 - 10 Jan	11 - 13 Mar	13 - 15 Mei	8 - 10 Jul	9 - 11 Sept	11 - 13 Nov
14 - 16 Jan	18 - 20 Mar	20 - 22 Mei	15 - 17 Jul	16 - 18 Sept	18 - 20 Nov
21 - 23 Jan	25 - 27 Mar	27 - 29 Mei	22 - 24 Jul	23 - 25 Sept	25 - 27 Nov
28 - 30 Jan	1 - 3 Apr	3 - 5 Jun	29 - 31 Jul	30 Sept - 2 Okt	2 - 4 Des
4 - 6 Feb	16 - 18 Apr	10 - 12 Jun	5 - 7 Agst	7 - 9 Okt	9 - 11 Des
11 - 13 Feb	23 - 25 Apr	17 - 19 Jun	12 - 14 Agst	14 - 16 Okt	16 - 18 Des
18 - 20 Feb		24 - 26 Jun	19 - 21 Agst	21 - 23 Okt	23 - 25 Des
25 - 27 Feb			26 - 28 Agst	28 - 30 Okt

Waktu dan tempat:

Pukul 08.30 – 16.00 WIB

Hotel Berbintang di Yogyakarta

Request for Training Venue: Semarang, Solo, Bandung, Jakarta, Balikpapan, Surabaya, Jogja, Lombok, Malang, Makassar and Batam

In House Training Depend on request