Monday, 11 April 2016

Workshop on Equipment Qualification

At Hotel Fern, Ahmedabad with participants from 3 units of Teva Pharma.
The concept of URS, FS, DS, DQ, FAT, SAT, IQ, OQ, PQ, PPQ, Validation, Verification, Calibration, Monitoring and Control were discussed and practised.
The group was extremely participative and knowledgeable and cases from their practical situation were discussed.

Thursday, 25 February 2016

CAPA at Sri Krishna Pharmaceuticals, Hyderabad

February 23rd and 24th 2016saw senior managers of Sri Krishna Pharmaceuticals spend time with Pravin Manker who facilitated a workshop on CAPA with live case studies from their 4 manufacturing units.

50 participants spent their time and energy vigorously discussing steps in CAPA starting with defining the deviation statement, failure investigation and root cause analysis.

Tools such as 5 why analysis, brainstorming, fishbone diagram, FMEA were put to practical use with robust debating among 4 groups formed with cross-unit and cross-functional team formation.

Overall the program was well received with many participants pledging to put the techniques learnt to practical use.

The highlight of the program was the presence of the Managing Director for a large part of the program showing the importance the company gives to training.

Saturday, 20 February 2016

Fwd: Hetero Vizag CAPA

Two days workshop on CAPA for Assistant Managers and above on 17th and 18th February 2016 at Hetero Nakkapalli plant.

60 participants worked on in house case studies and applied their minds in 7 groups.
Identification (Problem Definition)
Deviation Investigation
Analysis (RCA)
Corrective Action
Preventive Action
were discussed in a lively, robust yet friendly manner. 

The workshop was conducted by Prescription Pharma Support, a Mumbai based service provider to the Pharmaceutical industry worldwide.

The workshop leader was Pravin Manker

Friday, 29 January 2016

Team Building and Effectiveness

A workshop and training program held in Hyderabad for S. K. Pharmaceuticals on 27/1 and 28/1/16 for cross-functional Senior Managers and HODs.

36 members participated and were put through the theory and practical case studies on forming, storming, morning and performing, Do's and Don'ts, Team Building, Communication skills, Leadership skills and Good Habits to Develop.

The two days were intense, interactive and enjoyable with multiple takeaways for participants.

Thursday, 14 January 2016

Fwd: Attitude towards GMP

Subject: Attitude towards GMP

cGMP training programs are usually boring and technical because most people think they know all about GMP. It is not the content of GMP that is critical but the attitude of people who are expected to adopt GMP. Many GMP failures have occurred not because people were ignorant but because people did not have the right attitude. Ironically, the attitude cuts across the vertical hierarchical structure of an organization. 

Also, a level of complacency develops when an organization has gone through a few successful FDA and MHRA GMP audits. This complacency percolates down the line because a cross-section of employees, who know the flaws in their organizations, start believing that we can 'fool' all the auditors all the time.

A unique two-days workshop blending principles governing life and GMP was initiated on 30th December 2015 by Prescription Pharma Support, Mumbai and Sri Krishna Pharmaceuticals, Hyderabad.

Top officials from 4 manufacturing units, about 40 in number, participated. The departments represented were Manufacturing, Technical ServicesQC, QA, IT, HR, R&D, Warehouse, Engineering and Corporate Managers participated.

Laws of living and their relevance in professional life was the highlight of day 1. The backdrop was Lord Buddha's noble 8-fold path. This was organized in a meeting setup.

The second day was rearranged as clusters with teams formed from the members of the 4 units applying cross-functional and cross-locational mix.

Live case studies were discussed relating the noble 8-fold path to understanding deviations, investigations, root cause analysis,   writing SOPs and communication skills.

The unique experiment was well received and the participants and corporate managers expressed delight at the outcome of two fruitful days.